Status:
ACTIVE_NOT_RECRUITING
Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Brief Summary
This trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of...
Detailed Description
PRIMARY OBJECTIVES: I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including kpl, w...
Eligibility Criteria
Inclusion
- Biopsy proven prostate adenocarcinoma (Arm 1 \& 2)
- Clinically appropriate for active surveillance (Arm 1)
- Prior prostate biopsy must have been performed at least 5 weeks prior imaging (Arm 1 \& 2)
- Patient must be scheduled to undergo radical prostatectomy within 6 months of multi-parametric magnetic resonance imaging (MP-MRI) + hyperpolarized (HP) \[1-13C\]-pyruvate imaging, consistent with American College of Radiology Imaging Network (ACRIN) Protocol: ACRIN 6659 (Arm 2)
- At least 10% of enrolled patients will have high risk of disease progression (Cancer of the Prostate Risk Assessment - \[CAPRA\] 6-10) and no more than 50% of enrolled patients will have low risk of progression (CAPRA \< 3) (Arm 2)
Exclusion
- Contraindication to MRI (Arm 1 \& 2)
- Allergy to gadavist intravenous contrast (Arm 1 \& 2)
- Any known medical history of arrhythmias such as atrial fib, etc. (Arm 1 \& 2)
- Prior therapy for prostate cancer, except for 5-alpha reductase inhibitor discontinued at least one month prior to imaging (Arm 1 \& 2)
Key Trial Info
Start Date :
December 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04286386
Start Date
December 19 2019
End Date
April 30 2026
Last Update
October 27 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030