Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Hyperpolarized 13C-Pyruvate

Study type: Interventional

Funder types: Other

Identifiers

NCT04698564

18149GCCC HP-00084316;

Details and patient eligibility

About

This is a two-tiered pilot study in which there will be no randomization and no placebo treatment. This study will be to perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population

Enrollment: 20 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age greater than 40 and less than 80 years

2. Clinical suspicion or history of prostate cancer reflected by one of the following:

   • PSA > 4ng/ml
   • Abnormal DRE exam
   • Known tissue diagnosis of prostate cancer from prior workup

3. Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment

Exclusion criteria

1. Inability to undergo MRI scan
2. Inability to receive IV contrast as per institutional protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Single-arm study in patients who are suspected or known to have prostate cancer

Experimental group

Description:

Perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population

Treatment:

Drug: Hyperpolarized 13C-Pyruvate