Status:
TERMINATED
GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Background: \- GE-148 (18F) is a new drug that is designed to attach to prostate cancer cells. Researchers are interested in combining the drug with a small amount of radioactive material to allow pr...
Detailed Description
Background: * Accurate imaging of prostate cancer is important for developing targeted minimally invasive therapies * GE-148 (18F) Injection is a drug product formulation known as \[18F\]FACBC which ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subject is male and is greater than or equal to 18 years old.
- Subject must be scheduled to undergo standard of care prostatectomy for presumed localized prostate cancer at the NIH Clinical Center.
- Recent (within 12 months of study entry but not within 8-12 weeks before start of imaging study) prostate biopsy indicating the presence of adenocarcinoma of the prostate gland in which at least sextant biopsies were obtained.
- Subjects must have a minimum of 1 positive-for-cancer biopsy core.
- Serum creatinine within 2 weeks prior to MR imaging less than or equal to 1.8 mg/dl and eGFR must be greater than 30 ml/min/1.73m(2)
- Chemistry parameters: AST and ALT 2 x of the upper limits of normal; total bilirubin, of less than or equal to 2 x the upper limits of normal or less than 3.0 mg/dl in patients with Gilbert's syndrome.
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
- Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.
- The subject has a clinically acceptable medical history, physical examination and vital signs findings during the screening period (from within 21 days before administration of GE-148 (18F) Injection).
- EXCLUSION CRITERIA:
- Known allergy to gadolinium.
- Subjects for whom participating would significantly delay the scheduled standard of care therapy.
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
- Subjects with severe claustrophobia unresponsive to oral anxiolytics.
- Subjects with contraindications to MRI
- Subjects weighing more than 136 kg (weight limit for scanner table).
- Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
- Subjects with contraindication to endorectal coil placement
- Severe hemorrhoids.
- Surgically absent rectum.
- Other medical conditions deemed by the principle investigator (or associates) or sponsor to make the subject ineligible for protocol procedures.
- Subjects who have previously received radiation therapy to the pelvis.
- Subjects who have received androgen-deprivation therapy.
- The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 week after administration of GE-148 (18F) Injection.
- Subjects with chronic renal failure (eGFR less than 30 ml/min/1.73m(2)).
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01176513
Start Date
July 1 2010
End Date
March 1 2012
Last Update
February 14 2014
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892