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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
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
November 11, 2013
Last Updated
November 25, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
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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

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Functional MRI Use in Prostate Radiation Treatment Planning

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