Clinical trial NCT04495959: Dynamic Whole Body PET/ MRI
Official title: Dynamic Whole Body Positron Emission Tomography/ Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostatic Cancer
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed high risk prostate cancer (UCSF/CAPRA score of 6 or higher) who are scheduled to undergo radical prostatectomy.

Brief summary: Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return.Current conventional imaging modalities have limitations particularly at low prostate specific antigen levels. This study proposes to use 68Ga-HTK03149 Dynamic Whole Body (DWB) Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the prostate cancer has recurred.

Detailed description: This is a prospective registry study to evaluate the diagnostic utility of 68Ga-HTK03149 DWB PET/MRI to stage patients with high risk prostate cancer who will subsequently under go radical prostatectomy.

Eligible subjects will undergo a 68Ga-HTK03149 DWB PET/MRI at the University of British Columbia (UBC) - Vancouver, Djavad Mowafaghian Centre for Brain Health where the UBC PET/MRI is located. Each subject will receive a 18F-DCFPyL PET/MRI DWB scan at the UBC centre, as part of this research study. Each study subject will receive a bolus intravenous dose of 18F-DCFPyL. The subject will be placed on the PET/MRI scanner for a dynamic whole body PET scan. Then after a brief break off the scanner, they will return to the scanner for the standard whole body PET/MRI scan.

The PET/MRI scan will take approximately 3.5 hours of patient time above and beyond the time needed for standard of care.

Medical History Questionnaire: Demographic and medical history data will be collected either in person before the PET scan appointment or by mail or phone, whichever is the most convenient to the subject.

Follow-up assessments: All subjects will be contacted by phone the day after the injection of 68Ga-HTK03149. The subjects will be asked if they experienced any undesirable effects during the 12 hours after the administration of 68Ga-HTK03149. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 68Ga-HTK03149 administration.

All subjects will be followed for 5 years following the 68Ga-HTK03149 PET/CT exam to assess the presence of recurrence. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.

Eligibility criteria: Inclusion Criteria:

* Subjects with biopsy-proven high risk prostate cancer (UCSF/CAPRA score 6 or higher) scheduled for radical prostatectomy.
* Able to not use the washroom for the duration of the dynamic imaging scanning.
* Eastern Cooperative Oncology Group performance status of 2 or less.
* Able to lie supine for the required duration of the scans

Exclusion Criteria:

* Meet the exclusion criteria for the appropriate standard of care imaging.
* Experience claustrophobia.
* Subjects with severe renal disease or acutely deteriorating renal function (eGRF\<30 mL/min)
* Subjects may not take part in this study if they have a pacemaker, an implanted defibrillator, or certain other implanted electronic or metallic devices, shrapnel, or other metal.

Primary outcomes:
measure: Sensitivity of Dynamic Whole Body 68Ga-HTK03149PET/MRI imaging in the assessment of high risk prostate cancer.
timeFrame: 5 years after 68Ga-HTK03149DWB PET/MRI scan
Secondary outcomes:
measure: Accuracy of combined DWB PET/MRI to assess the extent of prostate cancer
timeFrame: 5 years after 68Ga-HTK03149 DWB PET/MRI scan
measure: Number of participants with self-reported 68Ga-HTK03149 related adverse event
timeFrame: 12 hours post 68Ga-HTK03149 injection
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
References: