Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Body Non-Contrast MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Restriction spectrum imaging, Magnetic resonance imaging, MRI, RSI
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.
Sites / Locations
- UC San Diego Moores Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Whole Body Non-Contrast MRI
Arm Description
Outcomes
Primary Outcome Measures
Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging
Paired t-test
Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03440554
First Posted
February 14, 2018
Last Updated
April 22, 2021
Sponsor
University of California, San Diego
Collaborators
Prostate Cancer Foundation, United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT03440554
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 24, 2016 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Prostate Cancer Foundation, United States Department of Defense
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Restriction spectrum imaging, Magnetic resonance imaging, MRI, RSI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole Body Non-Contrast MRI
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Whole Body Non-Contrast MRI
Intervention Description
Whole Body Non-Contrast MRI in Prostate Cancer Patients
Primary Outcome Measure Information:
Title
Specificity and Sensitivity of Whole Body MRI in Relation to Standard-of-Care Imaging
Description
Paired t-test
Time Frame
15 months
Title
Covariance of Whole Body MRI Cellularity Index (CI) and PET/CT Standardized Uptake Value (SUV)
Description
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.
Time Frame
15 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candace Winkler, MS
Phone
8588225398
Email
cmwinkler@ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael E Hahn, MD
Phone
(619)543-6641
Email
mehahn@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Hahn, MD
Organizational Affiliation
UC San Diego Moores Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candace M Winkler, MS
Phone
858-822-5398
Email
cmwinkler@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Christopher Sera
Phone
8585344822
Email
chsera@ucsd.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Non-contrast MR Imaging for Whole Body Cancer Detection and Characterization
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