Dynamic Whole Body PET/ MRI

Dynamic Whole Body Positron Emission Tomography/ Magnetic Resonance Imaging

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostatic Cancer
• Intervention / Treatment: Drug: 68Ga-HTK03149

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Heather Saprunoff; Phone Number: 2818 604-877-6000; Email: hsaprunoff@bccancer.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
68Ga-HTK03149 PET/MRI DWB scan; All participants will undergo the same procedures listed in "Detailed Description" in the protocol section.	Drug: 68Ga-HTK03149; PET/MRI scan with radiotracer 68Ga-HTK03149

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Dynamic Whole Body 68Ga-HTK03149PET/MRI imaging in the assessment of high risk prostate cancer.	Determination of sensitivity when compared with pathology reports	5 years after 68Ga-HTK03149DWB PET/MRI scan

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of combined DWB PET/MRI to assess the extent of prostate cancer	Comparison of parametric images derived from dynamic whole body PET imaging to conventional static PET images as well as MRI images . Assessment as to whether parametric images are able to distinguish normal organ accumulation (e.g. ureters, kidneys, bladder, bowel) from tumour uptake, based on the kinetics of radiotracer accumulation. Quantitative comparison of image contrast and signal-to-noise ratio (SNR) between static and parametric images from dynamic scans will be completed.	5 years after 68Ga-HTK03149 DWB PET/MRI scan
Number of participants with self-reported 68Ga-HTK03149 related adverse event	Patients will be contacted by phone the day after the 68Ga-HTK03149PET/CT scan to see if they experienced any adverse events in the 12 hours following the 18F-DCFPyL injection. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.	12 hours post 68Ga-HTK03149 injection

Collaborators and Investigators

• Sponsor: British Columbia Cancer Agency

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: H20-02418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No