Back to resultsMulti-parametric Magnetic Resonance Imaging for Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multiparametric MRI
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed prostate adenocarcinoma
Exclusion Criteria:
- Patients with metal fragments or implanted devices such as pacemakers and aneurysm clips are not eligible for the study considering
Sites / Locations
- Henry Ford Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multi-parametric MRI for Prostate Cancer
Arm Description
MRI will be acquired for prostate cancer patients undergoing radiation treatment.
Outcomes
Primary Outcome Measures
Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response
Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control.
Tumor Response
Tumor response as measured by an increase in PSA.
Secondary Outcome Measures
Full Information
NCT ID
NCT03180398
First Posted
June 5, 2017
Last Updated
September 21, 2023
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03180398
Brief Title
Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients
Official Title
Pilot Study of Using Multi-parametric Magnetic Resonance Imaging for Organ Delineation and Tumor Response Assessment of Prostate Cancer Patients Being Treated With Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
This is a pilot study of implement multi-parametric MR imaging for organ delineation and tumor response assessment of prostate cancer patients being treated with radiation therapy.
Detailed Description
The study aims to generate intraprostatic lesions maps based on imaging, perform the treatment planning to compute the highest feasible simultaneous boosting dose to intraprostatic lesion and characterize longitudinal changes in imaging characteristics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi-parametric MRI for Prostate Cancer
Arm Type
Experimental
Arm Description
MRI will be acquired for prostate cancer patients undergoing radiation treatment.
Intervention Type
Device
Intervention Name(s)
Multiparametric MRI
Intervention Description
MRI will be acquired before, during and after radiation treatment to evaluate treatment response
Primary Outcome Measure Information:
Title
Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response
Description
Identify the radiomics features selected from multimodal MRI to distinguish the dominant lesions from the normal tissues within the prostate. Track the changes of these features with longitudinal MRI scans to identify its correlation with the local control.
Time Frame
2 years
Title
Tumor Response
Description
Tumor response as measured by an increase in PSA.
Time Frame
2 years
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed prostate adenocarcinoma
Exclusion Criteria:
Patients with metal fragments or implanted devices such as pacemakers and aneurysm clips are not eligible for the study considering
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients
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