Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization

April 22, 2021 updated by: Michael Hahn, University of California, San Diego

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michael E Hahn, MD
  • Phone Number: (619)543-6641
  • Email: mehahn@ucsd.edu

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whole Body Non-Contrast MRI
Diagnostic test: Whole Body Non-Contrast MRI
Whole Body Non-Contrast MRI in Prostate Cancer Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging
Time Frame: 15 months
Paired t-test
15 months
Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV)
Time Frame: 15 months

For each identified lesion in the PET/CT, the lesion will be outlined, the size measured in millimeters, and the SUV will be calculated using the following equation:

SUV= (decay-(corrected activity (kBq))/(tissue volume (ml) ))/(injected=(FDG activity (kBq))/(body weight (g) ))

Baseline SUVs will also be calculated within normal appearing tissue.

Similarly, for each identified lesion in the whole-body RSI-MRI, the lesion will be outlined, the size measured as indicated above, and the CI will be calculated. Baseline CIs will also be calculated within normal appearing tissue.

The quantitative data will be analyzed for correlation across all lesions in all patients to determine the degree to which PET/CT SUV values and RSI-MRI CI values co-vary. Significance of the correlation coefficient, compared to zero correlation, will be assessed via the Student t-test, with alpha set to 0.05.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

United States Department of Defense
Prostate Cancer Foundation

Investigators

  • Principal Investigator: Michael E Hahn, MD, UC San Diego Moores Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

March 24, 2016

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151686

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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