Neuroendocrine TumorsNCT04017104
Dynamic Whole Body Positron Emission Tomography/Computed Tomography Imaging
An observational study of Neuroendocrine Tumors and Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- 18F-FDG PET/CT, 68Ga-DOTATOC PET/CT and 18F-DCFPyL PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- All subjects:
- Meet the inclusion criteria for the appropriate main study (68Ga-DOTATOC PET/CT or 18F-DCFPyL PET/CT) or standard of care imaging.
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Cancer
Vancouver, British Columbia, V5Z 4E6
Heather Saprunoff, 604-877-6000 ext. 2818, hsaprunoff@bccancer.bc.ca
Francois Benard, MD
About this study
Official title: 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
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.
Read the detailed description
This is a prospective single cohort study to evaluate the feasibility of dynamic whole body PET/CT in identifying and quantifying lesions where standard static PET has been negative or equivocal.
18F-FDG PET/CT - 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. 18F-FDG is considered standard care and has been approved by Health Canada. A fasting period of 6 hours is required before the scan. Diabetic participants should withhold short acting insulin during the fasting interval, and discuss with their physician whether to reduce long acting insulin the morning of the examination. Participants will also be instructed to drink 3 to 4 glasses of water within two hours prior to their scan appointment in order to promote hydration and facilitate urinary clearance of background radiopharmaceutical.
Prior to the 18F-FDG PET/CT procedure, participants will be instructed to take their usual medications as prescribed by their physician.
After providing informed written consent subjects will complete a medical history questionnaire.
The PET dynamic scan will start 30 minutes after the 18F-FDG injection. This will be followed by several whole body static acquisitions for a total scan time that will not be longer than 32 minutes.
After the DWB scan is finished, participants will be given the option to go to the washroom again. After this, a new PET/CT acquisition, as specified in the 18F-FDG PET/CT scan protocol, will immediately follow. Upon completion of the second PET scan, participants will be free to leave the department and will be encouraged to drink 3 - 4 extra glasses of water by the end of the day to promote further clearance of the remaining tracer in the urinary tract.
68Ga-DOTATOC PET/CT - 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. Prior to the 68Ga-DOTATOC PET/CT procedure, participants will be instructed to take their usual medications as prescribed by their physician. After providing informed written consent subjects will complete a medical history questionnaire. Participants will not be encouraged to drink additional water due to the requirement to stay on the scanner for up to 90 minutes (60 min DWB followed by standard PET acquisitions). There are no dietary restrictions.
After the DWB scan is finished, participants will be given the option to go to the washroom again and their vital signs will be recorded one more time. For this sub-study the vital signs will not be collected after the radiotracer injection to accommodate for the DWB protocol. After this, a new PET/CT acquisition, as specified in the 68Ga-DOTATOC PET/CT protocol, will immediately follow. Upon completion of the second PET scan, participants will be free to leave the department and will be encouraged to drink 3 - 4 extra glasses of water by the end of the day to promote further clearance of the remaining tracer in the urinary tract.
18F-DCFPyL PET/CT - 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.After providing informed written consent subjects will complete a medical history questionnaire. Prior to the 18F-DCFPyL PET/CT procedure, participants will be instructed to take their usual medications as prescribed by their physician. 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. The participant will receive a bolus intravenous dose of 18F-DCFPyL from an approved supplier, at a dose of approximately 296 MBq followed by a 5 to 20 mL normal saline flush and simultaneously a 6 minute dynamic acquisition of the heart will be started. 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 DWB scan is finished, the participant will be allowed to rest in a comfortable chair or bed for 30 minutes. During this time the vital signs will be recorded again. For this sub-study the vital signs will be measured before the radiotracer injection and again after the DWB PET scan to accommodate the DWB protocol. The participants will then be taken to a designated washroom and asked to void prior to the standard PET scan to clear excreted 18F-DCFPyL activity from the urinary tract.The participants will return to the scanner room and undergo the planned PET/CT imaging described in the main study.
Participant adverse event monitoring will be completed as part of regular standard of care (18F-FDG) or according to the main study protocols.
Follow-up Assessments - Follow-up information will be collected from the patient's medical records for up to 5 years following the PET/CT scan to obtain confirmatory information (from pathology and additional imaging showing progression or regression under treatment) about the status of known lesions.
The study is expected to take approximately 4 years for accrual.
- Conditions
- Neuroendocrine Tumors, Prostate Cancer, Prostatic Neoplasms, Carcinoid Tumor, Paraganglioma, Neuroblastoma
- Being tested
- 18F-FDG PET/CT, 68Ga-DOTATOC PET/CT, 18F-DCFPyL PET/CT
- Medical subject headings
- Neuroendocrine Tumors, Prostatic Neoplasms, Carcinoid Tumor, Paraganglioma, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTDiagnostic test
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.
68Ga-DOTATOC PET/CTDiagnostic test
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.
18F-DCFPyL PET/CTDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 18F-FDG PET/CT | |
| 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. Receives: Diagnostic Test: 68Ga-DOTATOC PET/CT | |
| 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. Receives: Diagnostic Test: 18F-DCFPyL PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Secondary outcomes (3)
Feasibility of dynamic whole body PET/CT imaging with technologists
Technologists will record whether there were any challenges with performing the scan. This will be recorded on a YES/NO assessment form.
Measured: 24 hours
Feasibility of dynamic whole body PET/CT imaging with clinical value
Image assessment will be performed by comparing the number of the 5 most active lesions identified in images that integrate the dynamic imaging portion with the number of the 5 most active lesions found in the standard PET/CT scan. Values will include the number of lesions, and quantitative parameters including lesion size and uptakes values.
Measured: 2 weeks
Confirm information about status of known lesions - progression or regression of lesions
Follow up information on progression or regression of lesions under treatment, will be collected from the patient's medical records following the PET/CT scan. Lesion size on imaging in millimeters will be collected.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Nov 2019
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Benard, MD, Principal investigator, BC Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017104
- Sponsor's protocol ID
- H19-00623
- Status last verified
- Jan 2021
- First submitted
- 27 May 2019
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04017104
- Acronym / sponsor ID
- H19-00623
- Conditions
- Neuroendocrine Tumors, Prostate Cancer, Prostatic Neoplasms, Carcinoid Tumor, Paraganglioma, Neuroblastoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective single cohort study to evaluate the feasibility of dynamic whole body PET/CT in identifying and quantifying lesions where standard static PET has been negative or equivocal.
18F-FDG PET/CT - 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. 18F-FDG is considered standard care and has been approved by Health Canada. A fasting period of 6 hours is required before the scan. Diabetic participants should withhold short acting insulin during the fasting interval, and discuss with their physician whether to reduce long acting insulin the morning of the examination. Participants will also be instructed to drink 3 to 4 glasses of water within two hours prior to their scan appointment in order to promote hydration and facilitate urinary clearance of background radiopharmaceutical.
Prior to the 18F-FDG PET/CT procedure, participants will be instructed to take their usual medications as prescribed by their physician.
After providing informed written consent subjects will complete a medical history questionnaire.
The PET dynamic scan will start 30 minutes after the 18F-FDG injection. This will be followed by several whole body static acquisitions for a total scan time that will not be longer than 32 minutes.
After the DWB scan is finished, participants will be given the option to go to the washroom again. After this, a new PET/CT acquisition, as specified in the 18F-FDG PET/CT scan protocol, will immediately follow. Upon completion of the second PET scan, participants will be free to leave the department and will be encouraged to drink 3 - 4 extra glasses of water by the end of the day to promote further clearance of the remaining tracer in the urinary tract.
68Ga-DOTATOC PET/CT - 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. Prior to the 68Ga-DOTATOC PET/CT procedure, participants will be instructed to take their usual medications as prescribed by their physician. After providing informed written consent subjects will complete a medical history questionnaire. Participants will not be encouraged to drink additional water due to the requirement to stay on the scanner for up to 90 minutes (60 min DWB followed by standard PET acquisitions). There are no dietary restrictions.
After the DWB scan is finished, participants will be given the option to go to the washroom again and their vital signs will be recorded one more time. For this sub-study the vital signs will not be collected after the radiotracer injection to accommodate for the DWB protocol. After this, a new PET/CT acquisition, as specified in the 68Ga-DOTATOC PET/CT protocol, will immediately follow. Upon completion of the second PET scan, participants will be free to leave the department and will be encouraged to drink 3 - 4 extra glasses of water by the end of the day to promote further clearance of the remaining tracer in the urinary tract.
18F-DCFPyL PET/CT - 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.After providing informed written consent subjects will complete a medical history questionnaire. Prior to the 18F-DCFPyL PET/CT procedure, participants will be instructed to take their usual medications as prescribed by their physician. 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. The participant will receive a bolus intravenous dose of 18F-DCFPyL from an approved supplier, at a dose of approximately 296 MBq followed by a 5 to 20 mL normal saline flush and simultaneously a 6 minute dynamic acquisition of the heart will be started. 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 DWB scan is finished, the participant will be allowed to rest in a comfortable chair or bed for 30 minutes. During this time the vital signs will be recorded again. For this sub-study the vital signs will be measured before the radiotracer injection and again after the DWB PET scan to accommodate the DWB protocol. The participants will then be taken to a designated washroom and asked to void prior to the standard PET scan to clear excreted 18F-DCFPyL activity from the urinary tract.The participants will return to the scanner room and undergo the planned PET/CT imaging described in the main study.
Participant adverse event monitoring will be completed as part of regular standard of care (18F-FDG) or according to the main study protocols.
Follow-up Assessments - Follow-up information will be collected from the patient's medical records for up to 5 years following the PET/CT scan to obtain confirmatory information (from pathology and additional imaging showing progression or regression under treatment) about the status of known lesions.
The study is expected to take approximately 4 years for accrual.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG PET/CT Diagnostic Imaging | – | Diagnostic Test: 18F-FDG PET/CTParticipants 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 | – | Diagnostic Test: 68Ga-DOTATOC PET/CTParticipants 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 | – | Diagnostic Test: 18F-DCFPyL PET/CTParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Meet the inclusion criteria for the appropriate main study (68Ga-DOTATOC PET/CT or 18F-DCFPyL PET/CT) or standard of care imaging.
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CTFor 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. | Diagnostic test | 18F-FDG PET/CT Diagnostic Imaging |
| 68Ga-DOTATOC PET/CTParticipants 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. | Diagnostic test | 68Ga-DOTATOC PET/CT Diagnostic Imaging |
| 18F-DCFPyL PET/CTParticipants 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. | Diagnostic test | 18F-DCFPyL PET/CT Diagnostic Imaging |
Primary outcome
Feasibility of dynamic whole body PET/CT imaging with participants: survey
Time frame: 24 hours
Feasibility will be measured using a survey that rates participant comfort on a scale from 1 (very uncomfortable) to 5 (very comfortable).
3 secondary outcomes
Feasibility of dynamic whole body PET/CT imaging with technologists
Time frame: 24 hours
Feasibility of dynamic whole body PET/CT imaging with clinical value
Time frame: 2 weeks
Confirm information about status of known lesions - progression or regression of lesions
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Benard, MD principal investigator
BC Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Saprunoff (604-877-6000 ext. 2818, hsaprunoff@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of dynamic whole body PET/CT imaging with participants: survey (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021; AzTrials last refreshed its copy on 31 Oct 2026.