Recruiting

Observational Study

Sponsor:

British Columbia Cancer Agency

Code:

NCT04017104

Conditions

Neuroendocrine Tumors

Prostate Cancer

Prostatic Neoplasms

Carcinoid Tumor

Paraganglioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-FDG PET/CT

68Ga-DOTATOC PET/CT

18F-DCFPyL PET/CT

Study Details

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.

Conditions

Neuroendocrine Tumors

Prostate Cancer

Prostatic Neoplasms

Carcinoid Tumor

Paraganglioma

Study ID

NCT04017104

Start date

Nov 1, 2019

Status verified date

Jan, 2021

Completion date

Aug 1, 2024

Anticipated

Primary completion date

Aug 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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

18F-FDG PET/CT

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/CT

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/CT

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.

Primary outcome measure

  • Feasibility of dynamic whole body PET/CT imaging with participants: survey [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Locations

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Principal Investigator:

Francois Benard, MD

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Jan 26, 2021

Last verified

Jan, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2021-01-26.