Magnetic Resonance Imaging as a Comprehensive Staging Tool for the Evaluation of High-Risk Prostate Carcinoma
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|ClinicalTrials.gov Identifier: NCT03085043|
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : April 20, 2018
The goal of this clinical research study is to compare 2 different types of magnetic resonance imaging (MRI). Researchers will compare diffusion-weighted imaging (a method to show how water moves in a certain area) with standard-of-care imaging to learn which method is better to check the status of prostate cancer.
This is an investigational study. The whole-body MRI scan in this study is performed using an FDA-approved and commercially available method. Having whole- body MRI with your standard-of-care MRI of the pelvis at the same time is investigational.
Up to 86 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Whole Body Magnetic Resonance Imaging (MRI) Procedure: Standard of Care Pelvic MRI Procedure: Bone Scan Procedure: Computed Tomography (CT)||Not Applicable|
If you agree, you will have a whole body MRI along with your standard-of-care MRI of the pelvis.
Adding the whole-body MRI imaging to your pelvic MRI will add about 20-30 minutes to the current standard-of-care MRI procedure. The total amount of time for the MRIs will be 60-70 minutes.
You will also have your standard-of-care bone scan and a computed tomography (CT) scan of your abdomen and pelvis. Researchers will compare the results of these procedures to your whole-body MRI.
Length of Study Participation:
All of the scans described above will be scheduled and completed within 90 days of signing this consent or before beginning any treatment. If you cannot complete the scans within 90 days or before beginning treatment, you will not be able to continue to take part in the study. Your active study participation will be over when the bone scan, CT scan, and whole body MRI scans are complete at initial visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Magnetic Resonance Imaging as a Comprehensive Staging Tool for the Evaluation of High-Risk Prostate Carcinoma|
|Actual Study Start Date :||April 20, 2016|
|Estimated Primary Completion Date :||April 2025|
|Estimated Study Completion Date :||April 2026|
Experimental: Whole-Body MRI Imaging
Participant has a whole body MRI along with standard-of-care MRI of the pelvis.
Participant also has standard-of-care bone scan and a computed tomography (CT) scan of abdomen and pelvis.
Scans performed at baseline and at 6 months.
Procedure: Whole Body Magnetic Resonance Imaging (MRI)
Whole body MRI with diffusion-weighted imaging performed at baseline and in 6 months.
Procedure: Standard of Care Pelvic MRI
Standard of care pelvic endorectal coil MRI performed at baseline and in 6 months.
Procedure: Bone Scan
Standard of care bone scan performed at baseline and in 6 months.
Procedure: Computed Tomography (CT)
CT abdomen and pelvis performed at baseline and in 6 months.
- Accuracy of Body MRI and Bone Scan plus CT in Detecting Metastasis in High Risk Prostate Cancer Participants [ Time Frame: 6 months ]Comparison between MRI and bone scan carried out using McNemar's test.
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): NCT03085043
|Contact: Tharakeswara K. Bathala, MD, MBBS||713-792-2533|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Tharakeswara K. Bathala, MD, MBBS||M.D. Anderson Cancer Center|