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Dynamic Whole Body Positron Emission Tomography/Computed Tomography Imaging

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ClinicalTrials.gov Identifier: NCT04017104
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency

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.


Condition or disease Intervention/treatment
Neuroendocrine Tumors Prostate Cancer Prostatic Neoplasms Carcinoid Tumor Paraganglioma Neuroblastoma Diagnostic Test: 18F-FDG PET/CT Diagnostic Test: 68Ga-DOTATOC PET/CT Diagnostic Test: 18F-DCFPyL PET/CT

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2024


Group/Cohort Intervention/treatment
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.

Diagnostic Test: 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 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.

Diagnostic Test: 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 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.

Diagnostic Test: 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 Measures :
  1. 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).


Secondary Outcome Measures :
  1. Feasibility of dynamic whole body PET/CT imaging with technologists [ Time Frame: 24 hours ]
    Technologists will record whether there were any challenges with performing the scan. This will be recorded on a YES/NO assessment form.

  2. Feasibility of dynamic whole body PET/CT imaging with clinical value [ Time Frame: 2 weeks ]
    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.

  3. Confirm information about status of known lesions - progression or regression of lesions [ Time Frame: 5 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017104


Contacts
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Contact: Heather Saprunoff 604-877-6000 ext 2818 hsaprunoff@bccancer.bc.ca

Locations
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Canada, British Columbia
BC Cancer Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Heather Saprunoff    604-877-6000 ext 2818    hsaprunoff@bccancer.bc.ca   
Principal Investigator: Francois Benard, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
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Principal Investigator: Francois Benard, MD BC Cancer

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT04017104     History of Changes
Other Study ID Numbers: H19-00623
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Neuroblastoma
Neuroendocrine Tumors
Carcinoid Tumor
Paraganglioma
Carotid Body Tumor
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Paraganglioma, Extra-Adrenal
Fluorodeoxyglucose F18
Edotreotide
Octreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal