Summary

for males ages 18 years and up (full criteria)
at La Jolla, California
study started
estimated completion:
Michael E Hahn

Description

Summary

This study aims to learn how to improve MRIs (Magnetic Resonance Imaging) that do not require the patient to be injected with a contrast dye. Researchers expect to learn how to better find and describe tumors in patients with prostate cancer. Participants have a whole body research MRI scan within 90 days of a standard-of-care imaging procedure. The research study will collect copies of those scans to compare to the research scans as part of the study analysis. Patients who have additional standard-of-care scans within 12 months after their research scan may be asked to have a second non-contrast MRI for research within 90 days of their follow-up standard of care imaging. The whole body MRI scan will be compared to the standard-of-care scan for prostate cancer detection and to assess patient response to standard-of-care treatment.

Details

Participants will undergo a whole body non-contrast MRI study with a whole-body protocol incorporating routine clinical sequences as well as non-contrast research sequences. The patient will also undergo clinically indicated standard-of-care imaging such as PET/CT, CT, Technetium-99m bone scan or MRI with contrast as determined by the patient's oncologist. When the standard-of-care imaging has not yet been performed upon enrollment, the research MRI will ideally be performed on the same day as the standard-of-care exam. However, scheduling constraints and patient time constraints may preclude scheduling both scans on the same day. In this case, the scans will be performed within a week 90 days of each other. An experienced radiologist will read both scans and results will be provided to the patient's oncologist for clinical follow up.

Patients receiving additional standard-of-care imaging within 12 months after the research MRI may be asked to return for an additional whole body MRI scan within 90 days of their standard-of-care scan. The additional research scan will be requested of patients that have evidence of progression during ongoing standard of care treatment and monitoring. The additional scan would be requested of those patients to compare baseline scans to those that are completed during standard of care imaging. This would be an additional tool to verify disease progression or treatment response.

Keywords

Prostate Cancer Restriction spectrum imaging Magnetic resonance imaging MRI RSI Prostatic Neoplasms Whole Body Non-Contrast MRI

Eligibility

You can join if…

Open to males ages 18 years and up

  • Patients must have known or suspected genitourinary metastatic disease and have already had or will have a CT, PET/CT, bone scan or MRI with contrast.
  • Age ≥ 18 years.
  • ECOG performance status 0-3.
  • Capacity to give informed consent.
  • Ability to lay supine for 30-60 minutes
  • Ability to hear adequately without hearing aids.

You CAN'T join if...

  • Prior or current use of: cardiac pacemaker, heart valve replacement, venous umbrella or filter, aneurysm surgery, intracranial bypass, renal or aortic clips, joint replacements, shunts/stents, metal mesh/coil implants, metal plates/pin/screws/wires or any other metal implants, neurostimulator, insulin pump, prosthetic devices such as middle ear, eye, joint, or penile implants, IUD, permanent eyeliner or eyebrows, metal fragments in eyes, skin, or body.
  • Patients who were previously or are currently employed as sheet-metal workers or welders.
  • Patients may be excluded if their weight exceeds 350 lbs, the limit for the safe operation of the MRI scanning table.
  • A patient who is pregnant or trying to become pregnant will be excluded.
  • Patients with any other condition that, in the opinion of the investigator, may deem them ineligible for study participation.

Location

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03440554
Lead Scientist
Michael E Hahn
Study Type
Interventional
Last Updated
February 14, 2018