Dynamic Whole Body PET/ MRI

NCT04495959 | Withdrawn

• 1 other identifier: H20-02418
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Accuracy of combined DWB PET/MRI to assess the extent of prostate cancer

  5 years after 68Ga-HTK03149 DWB PET/MRI scan

• Number of participants with self-reported 68Ga-HTK03149 related adverse event

  12 hours post 68Ga-HTK03149 injection

Study Arms (1)

68Ga-HTK03149 PET/MRI DWB scan

All participants will undergo the same procedures listed in "Detailed Description" in the protocol section.

Drug: 68Ga-HTK03149

Interventions

68Ga-HTK03149 DRUG

PET/MRI scan with radiotracer 68Ga-HTK03149

68Ga-HTK03149 PET/MRI DWB scan

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 3, 2020
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 8, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)