RECRUITING

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

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Conditions

Prostate CancerAdvanced Prostate CarcinomaHyperpolarized Pyruvate (13C)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) as a Diagnostic and Response Monitoring Imaging Tool in Advanced Prostate Cancer

Quick Facts

Study Start:2020-07-16
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04346225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically-confirmed locally advanced or metastatic prostate cancer. Patients with unequivocal clinical evidence supporting diagnosis of prostate cancer who have not had prior biopsy may be considered eligible per judgment of Principal Investigator.
  2. 2. Presence of at least one target lesion detected by standard staging scans that, in the judgment of Study Investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging:
  3. 1. Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on CT or MRI.
  4. 2. Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify).
  5. 3. For patients with target lesion in prostate/prostatic bed:
  6. 3. Able and willing to comply with study procedures and provide signed and dated informed consent.
  7. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  8. 5. For patients undergoing optional tumor biopsy:
  9. 1. No history of bleeding diathesis.
  10. 2. Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy.
  1. 1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
  2. 2. Patients unwilling or unable to undergo MR imaging, including patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
  3. 3. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MRI.
  4. 4. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures

Contacts and Locations

Study Contact

Maya Aslam
CONTACT
877-827-3222
Maya.Aslam@ucsf.edu

Principal Investigator

Ivan de Kouchkovsky, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Ivan de Kouchkovsky, MD

  • Ivan de Kouchkovsky, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-16
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2020-07-16
Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • Hyperpolarized Pyruvate (13C)

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Advanced Prostate Carcinoma