Clinical trial NCT03440554: Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization
Official title: Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Restriction spectrum imaging
Magnetic resonance imaging
MRI
RSI
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
name: United States Department of Defense
First posted: 2018-02-22
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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:

* 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.

Primary outcomes:
measure: Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging
timeFrame: 15 months
measure: Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV)
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
Study officials:
affiliation: UC San Diego Moores Cancer Center
name: Michael E Hahn, MD
role: PRINCIPAL_INVESTIGATOR
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