Functional MRI Use in Prostate Radiation Treatment Planning
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Male
- Biopsy proven prostate cancer without evidence of metastatic disease
- Planned definitive external beam RT with daily ERB and implanted Visicoil fiducial markers.
- Prior fMRI-ec documenting an IPL 25 mm2 in axial bidimensional diameter product, concordant with intraprostatic tumor location as documented on transrectal ultrasoundbiopsy
- Subject capable of giving informed consent for standard external beam RT and for the study.
- No current contraindication that would prevent MRI or gadolinium contrast.
Exclusion Criteria:
- Metastatic disease
- Lack of fMRI-ec documeneting an IPL 25 mm2 in axial bidimensional product, concordant with intraprostatic tumor location as documented on transrectal untrasound biopsy
- Neoadjuvant androgen deprivation therapy greater than 10 weeks, defined from date of LHRH analog injection to date of fMRI-sim
- Contraindication that would prevent MRI or gadolinium contrast
- GFR 30 mL/min/1.73m2 per Crockoft-Gault formula.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Functional MRI
Arm Description
Subjects in this arm receive functional MRI during radiation therapy treatment planning.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01985932
First Posted
November 11, 2013
Last Updated
November 25, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01985932
Brief Title
Functional MRI Use in Prostate Radiation Treatment Planning
Official Title
A Prospective Study Evaluating Non-Endorectal Coil Functional MRI Identification of Intraprostatic Tumor During Radiation Treatment Planning
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to evaluate the use of MRI during radiation treatment planning to identify areas of tumor within the prostate to aid in future treatment planning and targeting of prostate cancer. This study will be conducted at the University of Pennsylvania Health System. The study is projected to run for 18 months. Subjects will be male 18 or older with a prostate cancer diagnosis and treatment plansat the Department of Radiation Oncology.
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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional MRI
Arm Type
Other
Arm Description
Subjects in this arm receive functional MRI during radiation therapy treatment planning.
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Male
Biopsy proven prostate cancer without evidence of metastatic disease
Planned definitive external beam RT with daily ERB and implanted Visicoil fiducial markers.
Prior fMRI-ec documenting an IPL 25 mm2 in axial bidimensional diameter product, concordant with intraprostatic tumor location as documented on transrectal ultrasoundbiopsy
Subject capable of giving informed consent for standard external beam RT and for the study.
No current contraindication that would prevent MRI or gadolinium contrast.
Exclusion Criteria:
Metastatic disease
Lack of fMRI-ec documeneting an IPL 25 mm2 in axial bidimensional product, concordant with intraprostatic tumor location as documented on transrectal untrasound biopsy
Neoadjuvant androgen deprivation therapy greater than 10 weeks, defined from date of LHRH analog injection to date of fMRI-sim
Contraindication that would prevent MRI or gadolinium contrast
GFR 30 mL/min/1.73m2 per Crockoft-Gault formula.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtiland Deville, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Functional MRI Use in Prostate Radiation Treatment Planning
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