Recruiting

Whole Body Imaging

Sponsor:

UCLA

Code:

NCT03440554

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Whole Body Non-Contrast MRI

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT03440554

Start date

Mar 24, 2016

Status verified date

Apr, 2021

Completion date

Jan 1, 2023

Anticipated

Primary completion date

Mar 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with medical implants/devices or indwelling foreign material considered unsafe for MRI scanning will be excluded. Safety of medical implants/devices will be determined by the current UC San Diego Radiology and Imaging Services MRI safety policy. The name, manufacturer, and model number of any medical implant/device contained within a potential study subject will be obtained and reviewed to determine safety. Patients will be excluded if any implant/device is found to be unsafe for MRI scanning.
  • 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.

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Whole Body Non-Contrast MRI

Interventions

Whole Body Non-Contrast MRI

Whole Body Non-Contrast MRI in Prostate Cancer Patients

Primary outcome measure

  • Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging [ Time Frame: 15 months ]
  • Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV) [ Time Frame: 15 months ]

Central Contacts and Locations

Central contacts

Candace Winkler, MS

8588225398cmwinkler@ucsd.edu

Michael E Hahn, MD

(619)543-6641mehahn@ucsd.edu

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Candace M Winkler, MS

858-822-5398cmwinkler@ucsd.edu

Christopher Sera

8585344822chsera@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 26, 2021

Last verified

Apr, 2021

Keywords

  • Prostate Cancer
  • Restriction spectrum imaging
  • Magnetic resonance imaging
  • MRI
  • RSI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2021-04-26.