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1. Diagnostic accuracy and safety of 16α-[<sup>18</sup>F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study. (PubMed)

Diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study. A biopsy of first recurrence or metastatic disease is recommended to re-evaluate oestrogen receptor status in patients with breast cancer and to select appropriate treatment. However, retesting for oestrogen receptor status with rebiopsy is not always feasible, depending (...) on lesion location and the risk associated with biopsy, and in these cases clinicians continue to treat patients according to the oestrogen receptor status of the primary tumour. Consequently suboptimal therapy might be offered to these patients. We assessed the diagnostic accuracy and safety of 16α-[18F]fluoro-17β-oestradiol (18F-FES) PET-CT to assess oestrogen receptor status in patients with recurrent or metastatic breast cancer.We did a prospective cohort study at the Asan Medical Center, Seoul

2019 Lancet Oncology

2. [Evaluation of efficacy and safety of PET-CT (update)]

[Evaluation of efficacy and safety of PET-CT (update)] Evaluación de la seguridad y eficacia del PET-TAC (actualización) [Evaluation of efficacy and safety of PET-CT (update)] Evaluación de la seguridad y eficacia del PET-TAC (actualización) [Evaluation of efficacy and safety of PET-CT (update)] Zoni AC, Nováková V Citation Zoni AC, Nováková V. Evaluación de la seguridad y eficacia del PET-TAC (actualización) . [Evaluation of efficacy and safety of PET-CT (update)] Unidad de Evaluacion de (...) Tecnologias Sanitarias (UETS). Informes de Evaluación de Tecnologías Sanitarias. 2014 Authors' objectives The objective of the study was to evaluate the efficacy and safety of the hybrid PET/CT system in radiotherapy planning and to assess its impact on treatment outcomes. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Positron-Emission Tomographys Language Published Spanish Country of organisation Spain English summary An English language summary is available. Address

2015 Health Technology Assessment (HTA) Database.

3. Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)

Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2) Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (...) (SSTR2) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated

2018 Clinical Trials

4. PET Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines

tomography (PET) in the clinical management of patients with cancer, sarcoidosis, or epilepsy with respect to: ? Diagnosis and staging ? Assessment of treatment response ? Detection and restaging of recurrence ? Evaluation of metastasis Outcomes of interest are survival, quality of life, prognostic indicators, time until recurrence, safety outcomes (e.g., avoidance of unnecessary surgery), and change in clinical management. INTRODUCTION In 2010, the Ontario PET Steering Committee (the Committee (...) PET Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines 1 PET Six-Month Monitoring Report 2017-1 Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines January to June 2017 R. Poon and the Program in Evidence-Based Care Disease Site Group Reviewers Program in Evidence-Based Care (PEBC), Cancer Care Ontario (CCO) Report Date: December 18, 2017 QUESTION What is the role of positron emission

2018 Cancer Care Ontario

5. PET Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines

tomography (PET) in the clinical management of patients with cancer, sarcoidosis, or epilepsy with respect to: ? Diagnosis and staging ? Assessment of treatment response ? Detection and restaging of recurrence ? Evaluation of metastasis Outcomes of interest are survival, quality of life, prognostic indicators, time until recurrence, safety outcomes (e.g., avoidance of unnecessary surgery), and change in clinical management. INTRODUCTION In 2010, the Ontario PET Steering Committee (the Committee (...) PET Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines 1 PET Six-Month Monitoring Report 2018-1 Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines January to June 2018 R. Poon and the Program in Evidence-Based Care Disease Site Group Reviewers Program in Evidence-Based Care (PEBC), Cancer Care Ontario (CCO) Report Date: October 22, 2018 QUESTION What is the role of positron emission

2018 Cancer Care Ontario

6. PET-CT in investigating and or assessing patients for diagnosis and or staging of myeloma

identified studies had reported any patient or social aspects, nor had reported whether or not they looked for these outcomes. Safety The evidence used to inform the NICE Guideline found no evidence on radiation exposure from imaging tests for patients at either the diagnosis or newly-diagnosed stages of disease 5 . a There is a section of the report that describes pooled results for FDG PET/CT and FDG PET, but cites studies that are not listed in the references and have not been reported in any (...) PET-CT in investigating and or assessing patients for diagnosis and or staging of myeloma 79 1 Health technology description Key points ? The quantity and quality of the evidence base was not sufficient to determine the diagnostic accuracy of 18F-fluorodeoxyglucose (FDG) PET/CT in the context of investigating patients with suspected myeloma. ? In the assessment of newly-diagnosed myeloma patients, there was evidence that FDG PET/CT is likely to detect more lesions than x-ray, but when compared

2018 Evidence Notes from Healthcare Improvement Scotland

7. PET Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines

tomography (PET) in the clinical management of patients with cancer, sarcoidosis, or epilepsy with respect to: ? Diagnosis and staging ? Assessment of treatment response ? Detection and restaging of recurrence ? Evaluation of metastasis Outcomes of interest are survival, quality of life, prognostic indicators, time to recurrence, safety outcomes (e.g., avoidance of unnecessary surgery), and change in clinical management. INTRODUCTION In 2010, the Ontario PET Steering Committee (the Committee) requested (...) PET Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines 1 PET Six-Month Monitoring Report 2017-2 Evidence from Primary Studies and Systematic Reviews and Recommendations from Clinical Practice Guidelines July to December 2017 R. Poon and the Program in Evidence-Based Care Disease Site Group Reviewers Program in Evidence-Based Care (PEBC), Cancer Care Ontario (CCO) Report Date: May 1, 2018 QUESTION What is the role of positron emission

2018 Cancer Care Ontario

8. Examining the Public Provision and Funding of PET-CT Imaging for Non-cancer Indications

imaging.(62) In France, the French Society of Radiology and the French Society of Nuclear Medicine under the Haute Autorité de Santé and the Nuclear Safety Authority published the Guide to the Proper Use of Medical Imaging Exams.(32) In 2005, the Haute Autorité de Santé published an evaluation and state of practices regarding PET-CT imaging. While the report primarily focused on cancer indications, it stated that an extension of the indications is anticipated.(33) The guide is an online database (...) Examining the Public Provision and Funding of PET-CT Imaging for Non-cancer Indications Rapid Synthesis Examining the Public Provision and Funding of PET-CT Imaging for Non-cancer Indications 15 February 2018 McMaster Health Forum 1 Evidence >> Insight >> Action Rapid Synthesis: Examining the Public Provision and Funding of PET-CT Imaging for Non-cancer Indications 30-day response 15 February 2018 Examining the Public Provision and Funding of PET-CT Imaging for Non-cancer Indications 2 Evidence

2018 McMaster Health Forum

9. Gallium-68 PET Imaging in Neuroendocrine Tumours

that would be eligible for inclusion in the update of this recommendation report in the future. Safety & Efficacy of 68 Ga-DOTA-tyr3-Octreotide PET/CT in Diagnosis, Staging & Measurement of Response to Treatment in Patients With Somatostatin Receptor Positive Tumors: Comparison to Octreoscan Plus High-Resolution, Contrast Enhanced CT. Protocol ID: NCT01619865 Study type: Interventional Estimated enrollment: 200 Last updated: April 30, 2017 Estimated study completion date: December 2018 Sponsor (...) Gallium-68 PET Imaging in Neuroendocrine Tumours PET Recommendation Report 19 PET Recommendation Report 19 A Quality Initiative of the Program in Evidence-Based Care (PEBC), Cancer Care Ontario (CCO) Gallium-68 PET Imaging in Neuroendocrine Tumours S. Singh, R. Poon, R. Wong, U. Metser Report Date: November 26, 2018 For information about this document, please contact Dr. Simron Singh, the lead author, through the PEBC via: Phone: 905-527-4322 ext. 42822 Fax: 905 526-6775 E-mail: ccopgi

2018 Cancer Care Ontario

10. ACR–ASNR Practice Parameter for Brain PET/CT Imaging Dementia Res. 17 – 2015 - 2019

for qualified radiologic technologists and allows certified or registered nuclear medicine 6 / Brain Dementia PET/CT Imaging PRACTICE PARAMETER ? technologists who meet the educational and training requirements to take this examination. Eligibility criteria are located on the ARRT website (www.arrt.org). D. Radiation Safety Officer The radiation safety officer must meet applicable requirements of the Nuclear Regulatory Commission (NRC) for training as specified in 10 CFR 35.50 or equivalent state (...) and Improvement, Safety, Infection Control, and Patient Education appearing under the heading Position Statement on QC & Improvement, Safety, Infection Control, and Patient Education on the ACR website (http://www.acr.org/guidelines). For specific issues regarding CT quality control, see the ACR Practice Parameter for Performing and Interpreting Diagnostic Computed Tomography (CT) [29]. For specific issues regarding PET and PET/CT quality control, see section VIII on Equipment Quality Control. Equipment

2019 American Society of Neuroradiology

11. PET-CT imaging in patients with anal cancer

have attempted to measure treatment response too soon after treatment to reliably estimate effectiveness. Safety ? No adverse events relating to PET-CT in patients with anal cancer were reported in the systematic reviews. ? Undergoing a PET-CT scan represents an additional radiation burden for patients compared to CT alone. A PET-CT scan exposes patients to a radiation dose equivalent to 8 years of natural radiation exposure, for example from the sun, while a basic CT scan exposes patients (...) PET-CT imaging in patients with anal cancer Advice Statement | 1 Advice Statement 03-19 April 2019 Advice Statement 18 F-fluorodeoxyglucose (FDG) positron emission tomography – computed tomography (PET-CT) for routine staging and monitoring of treatment response in patients with anal cancer Advice for NHSScotland In primary tumour staging in patients diagnosed with anal cancer, FDG PET-CT should be considered as an adjunct to clinical assessment and magnetic resonance imaging (MRI) or computed

2019 SHTG Advice Statements

12. F-18 Fluorodeoxyglucose (FDG) positron emission tomography (PET) for the evaluation of breast cancer

) was received from the Australasian Association of Nuclear Medicine Specialists by the Department of Health. 2. MSAC’s advice to the Minister After considering the strength of the available evidence in relation to the comparative safety, clinical effectiveness and cost-effectiveness, MSAC supported public funding of FDG PET scanning for the evaluation of patients with breast cancer who are considered candidates for active treatment and: • who have locally advanced (stage III) disease, or • in whom recurrent (...) of imaging techniques, such as plain radiography, ultrasound, bone scintigraphy (i.e. nuclear medicine), CT and MRI. However, the imaging tests most commonly used for staging breast cancer are CT and bone scintigraphy. 10. Comparative safety As per the PSD for MSAC Application 1357, MSAC concluded that “PET has been reviewed previously by MSAC on multiple occasions and found to be a safe procedure. The studies included in this assessment did not raise any new safety concerns.” Consequently

2018 Medical Services Advisory Committee

13. FES (16α-[18F]-Fluoro-17β-estradiol)-PET: Towards a New Standard to Stage Locally Advanced and Recurrent, Estrogen Receptor Positive (ER+) Breast Cancer? Pilot Study to Compare [18F]FES-PET and [18F]FDG-PET

: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. FES (16α-[18F]-Fluoro-17β-estradiol)-PET: Towards a New Standard to Stage Locally Advanced and Recurrent, Estrogen Receptor Positive (ER+) Breast Cancer? Pilot Study to Compare [18F]FES-PET and [18F]FDG-PET (FORESIGHT) The safety and scientific (...) FES (16α-[18F]-Fluoro-17β-estradiol)-PET: Towards a New Standard to Stage Locally Advanced and Recurrent, Estrogen Receptor Positive (ER+) Breast Cancer? Pilot Study to Compare [18F]FES-PET and [18F]FDG-PET FES (16α-[18F]-Fluoro-17β-estradiol)-PET: Towards a New Standard to Stage Locally Advanced and Recurrent, Estrogen Receptor Positive (ER+) Breast Cancer? Pilot Study to Compare [18F]FES-PET and [18F]FDG-PET - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers

2018 Clinical Trials

14. 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety

18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety 18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. 18F-DOPA PET Imaging (...) disease Pediatric or Adult patients with primary brain tumors This study will evaluate the biodistribution and safety of 18F-DOPA produced at the Edmonton PET Centre. Condition or disease Intervention/treatment Phase Congenital Hyperinsulinism Neuroblastoma Neuroendocrine Tumors Parkinson Disease Brain Glioma Drug: 18F-DOPA Phase 3 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 400 participants Intervention Model: Single Group

2017 Clinical Trials

15. Initial multicentre experience of <sup>68</sup> Gallium-PSMA PET/CT guided robot-assisted salvage lymphadenectomy: acceptable safety profile but oncological benefit appears limited. (PubMed)

Initial multicentre experience of 68 Gallium-PSMA PET/CT guided robot-assisted salvage lymphadenectomy: acceptable safety profile but oncological benefit appears limited. To evaluate the safety and short-term oncological outcomes of 68 gallium-labelled prostate-specific membrane antigen (68 Ga-PSMA) positron-emission tomography (PET)/computed tomography (CT)-directed robot-assisted salvage node dissection (RASND) for prostate cancer oligometastatic nodal recurrence.Between February (...) 2014 and April 2016, 35 patients across two centres underwent RASND for 68 Ga-PSMA PET/CT-detected oligometastatic nodal recurrence. RASND was performed using targeted pelvic dissection, unilateral extended pelvic template or bilateral extended pelvic template dissection, depending on previous pelvic treatment and extent/location of nodal disease. Complications were reported using the Clavien-Dindo classification system. Definitions of prostate-specific antigen (PSA) treatment response to RASND

2017 BJU international

16. Safety of PET MPI Using the CRCHUM N-13 Ammonia

Safety of PET MPI Using the CRCHUM N-13 Ammonia Safety of PET MPI Using the CRCHUM N-13 Ammonia - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Safety of PET MPI Using the CRCHUM N-13 Ammonia The safety (...) of NH3 produced at the CRCHUM is experimental. The main objective of this research study is to validate the production process and assess the safety of the NH3 produced at the CRCHUM cyclotron. Secondary objectives include the assessment of prescription practices amongst physicians who refer patients for PET MPI, and how they will change over time. Condition or disease Intervention/treatment Phase N-13 Ammonia Safety Drug: N-13 ammonia intravenous injection Phase 4 Study Design Go to Layout table

2017 Clinical Trials

17. Safety and accuracy of 68Ga-DOTATOC PET/CT in children and young adults with solid tumors (PubMed)

Safety and accuracy of 68Ga-DOTATOC PET/CT in children and young adults with solid tumors 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) PET/CT has been shown to have high accuracy in adults with neuroendocrine tumors, however has not been studied in pediatric patients. This study evaluated the safety and accuracy of 68Ga-DOTATOC PET/CT in children and young adults with solid tumors that express somatostatin receptor type 2. A series of three prospective, IRB approved, clinical trials evaluating (...) safety and efficacy of 68Ga-DOTATOC PET/CT were conducted for subjects aged 6 months to 90 years. This study reports the results for the 26 children and young adults, aged 16 months to 29 years who participated in these trials. The administered activity of 68Ga-DOTATOC was 1.59 MBq/kg with an upper limit of 111 MBq for subjects < 18 years and 148 MBq for young adults. Safety was assessed with laboratory studies and patient/parent report of symptoms before and after the scan. Scans were interpreted

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2017 American journal of nuclear medicine and molecular imaging

18. 18F--tetrafluoroborate (18F--TFB), a PET probe for imaging sodium-iodide symporter expression: Whole-body biodistribution, safety and radiation dosimetry in thyroid cancer patients (PubMed)

18F--tetrafluoroborate (18F--TFB), a PET probe for imaging sodium-iodide symporter expression: Whole-body biodistribution, safety and radiation dosimetry in thyroid cancer patients We report the safety, biodistribution, and internal radiation dosimetry, in humans with thyroid cancer, of 18F-tetrafluoroborate (18F-TFB), a novel PET radioligand for imaging the human sodium/iodide symporter (hNIS). Methods: Serial whole-body PET scans of 5 subjects with recently diagnosed thyroid cancer were (...) acquired before surgery for up to 4 h after injection of 184 ± 15 MBq of 18F-TFB. Activity was determined in whole blood, plasma, and urine. Mean organ-absorbed doses and effective doses were calculated via quantitative image analysis and using OLINDA/EXM software. Results: Images showed a high uptake of 18F-TFB in known areas of high hNIS expression (thyroid, salivary glands, and stomach). Excretion was predominantly renal. No adverse effects in relation to safety of the radiopharmaceutical were

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2017 Journal of nuclear medicine : official publication, Society of Nuclear Medicine

19. A phase one, single-dose, open-label, clinical safety and PET/MR imaging study of 68Ga-DOTATOC in healthy volunteers (PubMed)

A phase one, single-dose, open-label, clinical safety and PET/MR imaging study of 68Ga-DOTATOC in healthy volunteers This prospective pilot study provides a dynamic whole body PET/MR image database, clinical safety, biodistribution profile and dosimetry of 68Ga-DOTATOC in healthy subjects, to establish a baseline and standard reference for its use in diagnosis and treatment response evaluation among patients with somatostatin receptor expressing neoplastic diseases. Dynamic whole body PET/MR (...) imaging was performed in 12 healthy subjects (male/female: 8/4) after injection of 242.39 ± 53.38 MBq (mean ± SD) 68Ga-DOTATOC. Images were acquired 15, 60, 120, and 240 minutes post injection. Subjects were assessed at baseline and after 68Ga-DOTATOC PET/MR by monitoring vital signs, 12-lead electrocardiograms, complete blood count, comprehensive metabolic panel, and urinalysis. Adverse events were monitored for one week after injection. Organ dosimetry was estimated using OLINDA/EXM 1.1 software

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2017 American journal of nuclear medicine and molecular imaging

20. Non-FDG tracers for use in PET-CT for suspected recurrent prostate cancer

likelihood of detecting extra-prostatic disease and this difference was also statistically significant (p=0.007). This was based on two small studies. Ongoing studies A UK multicentre trial assessing the clinical utility of anti- 18 F-FACBC PET-CT in biochemically recurrent prostate cancer is due to complete in early 2017 (NCT02578940; FALCON trial). A comparison with choline tracers will be performed in a subset of patients in the study. Safety Evidence on the safety of non-FDG tracers in PET-CT (...) in staging of recurrent prostate cancer was limited. In the secondary evidence identified, the safety of non-FDG tracers was not reported. In the primary evidence, Afshar- Oromieh et al (2014) 22 and Nanni et al (2015) 23 reported that there were no adverse effects with 68 Ga-PSMA or 18 F-choline PET-CT, and anti- 18 F-FACBC or 11 C-choline PET-CT respectively. Cost effectiveness No primary or secondary evidence was identified which assessed the cost effectiveness of non-FDG tracers in PET-CT

2017 Evidence Notes from Healthcare Improvement Scotland

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