Dynamic Whole Body Positron Emission Tomography/Computed Tomography Imaging
A Sub-study of 18F-DCFPyL Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of Recurrent Prostate Cancer Evaluation of the Safety and Sensitivity of 68Ga-DOTATOC PET/CT for Imaging NET Patients
1 other identifier
observational
60
1 country
1
Brief Summary
Quantitative parameters obtained with dynamic whole body imaging using positron emission tomography (PET) can provide additional and complementary information to standard PET. Dynamic imaging allows for better understanding of the behavior of the radio-pharmaceutical because it can be followed over time. Thought to be difficult to perform with currently available clinical equipment that can affect the clinical workflow, it has recently shown to be feasible. We want to test the feasibility of this imaging technique and evaluate its utility in identifying lesions with three different radio-pharmaceuticals as compared to standard static PET. This study will also determine the clinical impact of DWB PET on participant management by comparing the overall qualitative assessment performed by nuclear medicine physicians between the standard PET images and the DWB ones.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJanuary 26, 2021
January 1, 2021
2.8 years
May 27, 2019
January 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of dynamic whole body PET/CT imaging with participants: survey
Feasibility will be measured using a survey that rates participant comfort on a scale from 1 (very uncomfortable) to 5 (very comfortable).
24 hours
Secondary Outcomes (3)
Feasibility of dynamic whole body PET/CT imaging with technologists
24 hours
Feasibility of dynamic whole body PET/CT imaging with clinical value
2 weeks
Confirm information about status of known lesions - progression or regression of lesions
5 years
Study Arms (3)
18F-FDG PET/CT Diagnostic Imaging
Participants that have been chosen and consented to participate in the optional DWB PET/CT scan sub-study will undergo an extra 18F-FDG PET/CT procedure. 18FFDG is considered standard care and has been approved by Health Canada.
68Ga-DOTATOC PET/CT Diagnostic Imaging
Participants that have been chosen and consented to participate in the optional DWB PET/CT scan sub-study will undergo an extra 68Ga-DOTATOC PET/CT procedure. The 68Ga-DOTATOC radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada.
18F-DCFPyL PET/CT Diagnostic Imaging
Participants that have been chosen and consented to participate in the optional DWB PET/CT scan sub-study will undergo an extra 18F-DCFPyL PET/CT procedure. The 18F-DCFPyL radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada.
Interventions
For 18F-FDG as fasting period of 6 hours is required before the scan. Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.The participant will rest in a comfortable chair for 20 minutes. The participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. The participant will then be taken to the PET/CT scanner. Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
Participants will not be encouraged to drink additional water due to the requirement to stay on the scanner for up to 90 minutes. There are no dietary restrictions. Each study subject will have an intravenous catheter inserted. The participants will then be taken to a designated washroom and asked to void, and will then be taken to the PET/CT scanner. A CT topogram will be acquired followed by very low dose whole body CT for attenuation correction and localization of PET emission data. The participant will receive a bolus intravenous dose of the radiotracer 68Ga-DOTATOC from an approved study supplier site. Simultaneously a 6 minute dynamic acquisition of the heart will be started, then followed by several whole body static acquisitions. After the DWB scan, participants may go to the washroom again and their vital signs will be recorded. After this, a new PET/CT acquisition, as specified in the 68Ga-DOTATOC PET/CT protocol, will immediately follow.
Participants will not be encouraged to drink additional water due to the requirement to stay on the scanner for 90 minutes of the DWB acquisition. They will be unable to use the washroom during this time. As with the main study, participants will be instructed to fast for 4 hours prior to their appointment. Each study subject will have an intravenous catheter inserted. The participants will then be taken to a designated washroom and asked to void, and will then be taken to the PET/CT scanner. The participant will receive a bolus intravenous dose of 18F-DCFPyL from an approved supplier. This will then be followed by several whole body static acquisitions for a total scan time that will not be longer than 90 minutes. After the scan is finished, the participant will be allowed to rest in a comfortable chair or bed for 30 minutes. The participants will return to the scanner room and undergo the planned PET/CT imaging described in the main study.
Eligibility Criteria
The purpose of this study is to evaluate the diagnostic utility of DWB PET/CT in identifying and quantifying lesions where standard PET imaging (i.e. static) have been negative or equivocal. Concordance with histology, imaging or follow-up, using the data collected in the main studies, will also be assessed. This study will also determine the clinical impact of DWB PET on participant management by comparing the overall qualitative assessment performed by nuclear medicine physicians between the standard PET images and the DWB ones.
You may qualify if:
- All subjects:
- Able to not use the washroom for the duration of the dynamic imaging scanning.
- World health organization performance status 0-2
- Able to provide written informed consent/assent (or consent by guardian for subjects \<19 years)
- Patients must be able to tolerate the physical/logistical requirements of completing a PET scan including lying flat for up to 30 minutes and tolerating intravenous cannulation for injection.
You may not qualify if:
- Pregnancy
- Unable to provide written consent
- Patients who are medically unstable ex: acute cardiac or respiratory distress, hypotensive
- Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT bore (diameter 70cm).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Cancer
Vancouver, British Columbia, V5Z 4E6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francois Benard, MD
BC Cancer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2019
First Posted
July 12, 2019
Study Start
November 1, 2019
Primary Completion
August 1, 2022
Study Completion
August 1, 2024
Last Updated
January 26, 2021
Record last verified: 2021-01