Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional MRI Use in Prostate Radiation Treatment Planning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01985932
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: MRI Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study Evaluating Non-Endorectal Coil Functional MRI Identification of Intraprostatic Tumor During Radiation Treatment Planning
Study Start Date : July 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Functional MRI
Subjects in this arm receive functional MRI during radiation therapy treatment planning.
Device: MRI



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT01985932


Locations
Layout table for location information
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Curtiland Deville, MD Abramson Cancer Center of the University of Pennsylvania

Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01985932     History of Changes
Other Study ID Numbers: UPCC 07812
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases