Status:
COMPLETED
Magnetic Resonance Imaging to Evaluate Prostate Cancer
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Brief Summary
This study will determine whether scanning the prostate using special magnetic resonance imaging (MRI) techniques can detect prostate cancers with greater accuracy than other methods. MRI uses a stron...
Detailed Description
Progress in effective local therapy of prostate cancer has been stymied by the lack of an imaging technique capable of reliably identifying the location of cancer within the prostate. Magnetic Resonan...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Recent transrectal biopsy of the prostate gland in which at least sextant biopsies were obtained. Knowledge of the location of each specimen is required for inclusion.
- Age greater than or equal to18 years.
- ECOG performance status of 0 or 1.
- 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:
- Patients with contraindication to endorectal coil placement.
- Bleeding disorder documented by history.
- Severe immunocompromise documented by history.
- PT/PTT greater than 1.5 times the upper limit of normal.
- Platelets less than 50K.
- Artificial heart valve.
- Severe hemorrhoids.
- Surgically absent rectum.
- Patients with contraindications to MRI.
- Patients weighing greater than 136 kg (weight limit for scanner table).
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices not compatible with MRI.
- Patients with contraindications to prostate biopsy.
- See above contraindications for endorectal coil placement.
- Previous severe adverse event with prostatic biopsies.
- Patients with distant metastatic disease.
- Patients with a prior history of pelvic or prostate radiotherapy.
- Patient with a prior history of androgen ablative hormonal therapy (orchiectomy, LHRH analogues, anti-androgens).
- Cognitively impaired patients who cannot give informed consent.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures.
Exclusion
Key Trial Info
Start Date :
February 2 2004
Trial Type :
OBSERVATIONAL
End Date :
September 6 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00182624
Start Date
February 2 2004
End Date
September 6 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892