Functional MRI Use in Prostate Radiation Treatment Planning

NCT01985932 | Completed Results DMC

• 1 other identifier: UPCC 07812
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  2 years

Study Arms (1)

Functional MRI

OTHER

Subjects in this arm receive functional MRI during radiation therapy treatment planning.

Device: MRI

Interventions

MRI DEVICE

Functional MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Curtiland Deville, MD
• Organization: University of Pennsylvania

deville@uphs.upenn.edu

215-662-2428

Study Officials

• Curtiland Deville, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: July 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 26, 2019
• Results First Posted: November 26, 2019

Record last verified: 2019-11

Locations

US (1)