Status:
COMPLETED
Magnetic Resonance Imaging to Locate and Characterize Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-90 years
Phase:
NA
Brief Summary
This study will examine the usefulness of an imaging procedure called dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for localizing and characterizing prostate cancer. For this test, a...
Detailed Description
Accurate spatial delineation and biologic characterization of tumors within the prostate gland by non-invasive means, such as MR imaging, stands to impact the spectrum of prostate cancer care. At pres...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- ECOG performance status 0 or 1.
- Patients with a TRUS-guided biopsy for suspected prostate cancer in the past twelve months, or patients with pathologically confirmed adenocarcinoma of the prostate gland and who have not received definitive local therapy.
- Age greater than or equal to 18 years.
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
- EXCLUSION CRITERIA:
- Contraindication to trans-rectal biopsy:
- Bleeding disorder;
- PT/PTT greater than or equal to 1.5 times the upper limit of normal;
- Platelets less than or equal to 50K;
- Active anticoagulation;
- Severe immunocompromise;
- Severe hemorrhoids;
- Surgically absent rectum.
- Contraindication to MRI:
- Patients weighing greater than 136 kgs (weight limit for the scanner tables);
- Allergy to MR contrast agent;
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.
- Allergy to local anesthetics or quinolone antibiotics.
- Patients with a known diagnosis of prostate cancer and a known treatment plan to proceed to prostatectomy if the result of the biopsy would not affect surgical management.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures.
Exclusion
Key Trial Info
Start Date :
April 29 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00082147
Start Date
April 29 2004
End Date
June 11 2018
Last Update
June 13 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892