Comparison of Endorectal Coil Magnetic Resonance Imaging Versus Pelvic Digital Coil Resonance Magnetic Imaging at 3 Tesla for Detection and Local Staging of Prostate Cancer

Study ID
STU 072012-070

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • UT Southwestern-Other

Contact
Debra Travalini
214/645-2703
DEBBIE.TRAVALINI@UTSouthwestern.edu

Principal Investigator
Daniel Costa, M.D.

Summary

aim 1: The first stage of this study will compare PC-MRi using digital and analog coils with eC-MRi using a prostate phantom and healthy study subjects.
aim 1a: a prostate phantom will be used to compare PC-MRi using digital and analog coils with eC-MRi. The signal intensity, noise, and SnR will be measured for different MRi sequences.
aim 1b: Healthy study subjects will be used to compare digital PC-MRi to analog PC-MRi. The signal intensity, noise, and the SnR obtained with the analog and digital coils will be compared for each subject. The effect of the body habitus and also the effect of the distance between the pelvic coil and the prostate on SnR will be evaluated.

aim 2: The second stage of this study will be a prospective clinical trial which will compare our current clinical eC-MRi (which includes analog PC-MRi) to the research digital PC-MRi.

all of the patients at our institution who have a clinical indication to perform a 3T eC-MRi will be eligible for the study; including patients with suspected or known PCa. The patients who agree to participate in the study will undergo a 3T digital PC-MRi in addition to their standard of care eC-MRi at the completion of their MRi scan, they will complete a questionnaire evaluating and comparing their experience with the eC-MRi and the digital PC-MRi. .once this single visit is complete, subjects will resume normal activity and follow their routine clinical care as per their PCP

To compare the diagnostic performance of the eC-MRi and the digital PC-MRi, images will be reviewed and compared with the subject's histology from their prostatectomy or targeted transrectal ultrasound-guided biopsy.

Participant Eligibility

A). Sub-study (Health study subjects):
Inclusion Criteria:

* Males

* Adults age 18 to 65.

* Willing to participate under the conditions described in the Informed Consent form (ICF).

* Must be able to sign the ICF and applicable HIPAA forms.

* Must be willing to undergo screening for MRI procedures.


B). Clinical Main Study (Patient study subjects):
Inclusion Criteria:

* Males

* Adults age 18 and over.

* Patients with clinically suspected or histologically confirmed adenocarcinoma of the prostate that have indication for EC-MRI.

* Willing to participate under the conditions described in the Informed Consent form (ICF).

* Must be able to sign the ICF and applicable HIPAA forms.

* Must be willing to undergo screening for MRI procedures.