Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT04346225

Magnetic Resonance Imaging (MRI) With Hyperpolarized Pyruvate (13C) as Diagnostic Tool in Advanced Prostate Cancer

Led by Ivan de Kouchkovsky, MD · Updated on 2024-07-03

75

Participants Needed

1

Research Sites

332 weeks

Total Duration

On this page

Sponsors

I

Ivan de Kouchkovsky, MD

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging as a diagnostic and response monitoring tool in patients with advanced prostate cancer. Preliminary pre-clinical and clinical data demonstrates the ability of HP C-13 pyruvate/metabolic MR imaging to detect high-grade prostate cancer, including cancer with neuroendocrine differentiation, as well as provide early evidence of metabolic response and resistance following application of systemic therapies for the treatment of advanced prostate cancer patients. In the proposed study, the investigators aim is to extend the initial clinical results and further develop HP C-13 MRI as an imaging modality in advanced prostate cancer.

CONDITIONS

Official Title

Magnetic Resonance Imaging (MRI) With Hyperpolarized Pyruvate (13C) as Diagnostic Tool in Advanced Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed locally advanced or metastatic prostate cancer, or clear clinical evidence if no biopsy has been done
  • Presence of at least one target lesion visible on CT or MRI suitable for hyperpolarized C-13 pyruvate metabolic MR imaging
  • Soft tissue or visceral lesions must be at least 1 cm in size on CT or MRI
  • Bone lesions must be visible by CT or MRI (bone scan only lesions do not qualify)
  • For prostate or prostatic bed lesions: no contraindications to endorectal coil insertion and no prior local treatment or evidence of progression after local therapy
  • Able and willing to comply with study procedures and provide signed informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • For optional tumor biopsy: no bleeding disorders and ability to safely stop anticoagulation if needed
Not Eligible

You will not qualify if you...

  • Unable to give valid informed consent due to age, medical, or psychiatric conditions
  • Unable or unwilling to undergo MRI, including those with incompatible devices like pacemakers or intracranial clips
  • Presence of metallic implants that distort MRI images
  • Any condition that may impair ability to comply with study procedures as judged by the Principal Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

M

Maya Aslam

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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