Status:
COMPLETED
Positron Emission Tomography and Magnetic Resonance Imaging for Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: * Prostate cancers are difficult to see on most imaging studies such as X-rays, computed tomography (CT) scans, conventional magnetic resonance imaging (MRI) scans and conventional positr...
Detailed Description
Background: * Accurate localization of prostate cancer (PC) is important in developing targeted minimally invasive therapies. While T2 weighted imaging, dynamic contrast enhanced (DCE) imaging, diffu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the National Institutes of Health (NIH) Clinical Center.
- Recent (within 12 months of study entry) trans-rectal biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained. Knowledge of the location of each specimen is required for inclusion.
- Participant must be 18 years or older.
- Serum creatinine within 1 week prior to magnetic resonance (MR) imaging less than or equal to 1.8mg/dl AND epidermal growth factor receptor (eGFR) must be greater than 30 ml/min/1.73 m\^2
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1.
- Ability to provide 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:
- Known allergy to gadolinium or acetate.
- Participants for whom participating would significantly delay the scheduled standard of care therapy.
- Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.
- Participants with severe claustrophobia.
- Patients with contraindications to magnetic resonance imaging (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 or metal not compatible with MRI.
- Patients with contraindication to endorectal coil placement
- Severe hemorrhoids.
- Surgically absent rectum.
- Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for protocol procedures.
- Patients who have previously received radiation therapy to the pelvis.
- Patients who have received androgen deprivation therapy.
Exclusion
Key Trial Info
Start Date :
September 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00924313
Start Date
September 10 2008
End Date
April 19 2011
Last Update
July 11 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892