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

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ClinicalTrials.gov Identifier: NCT03440554
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Collaborators:
Prostate Cancer Foundation
United States Department of Defense
Information provided by (Responsible Party):
Michael Hahn, University of California, San Diego

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: Whole Body Non-Contrast MRI Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prostate cancer patients will have a research whole body MRI scan within 90 days of their standard of care imaging. Patients receiving additional standard of care imaging within 12 months of the research scan will be asked to have an additional research scan within 90 days of their follow-up imaging.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization
Actual Study Start Date : March 24, 2016
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging [ Time Frame: 15 months ]
    Paired t-test

  2. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440554


Contacts
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Contact: Candace Winkler, MS 8588225398 cmwinkler@ucsd.edu
Contact: Michael E Hahn, MD (619)543-6641 mehahn@ucsd.edu

Locations
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United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Candace M Winkler, MS    858-822-5398    cmwinkler@ucsd.edu   
Contact: Arlene Araneta    8588226187    aaraneta@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Prostate Cancer Foundation
United States Department of Defense
Investigators
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Principal Investigator: Michael E Hahn, MD UC San Diego Moores Cancer Center

Publications:

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Responsible Party: Michael Hahn, Assistant Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03440554     History of Changes
Other Study ID Numbers: 151686
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Hahn, University of California, San Diego:
Prostate Cancer
Restriction spectrum imaging
Magnetic resonance imaging
MRI
RSI
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases