GE148-002: A Phase 2, Open-label, Single-Center, Study to Assess GE-148 (18F) Injection Positron Emission Tomography(PET) Imaging to Detect Localized Prostate Cancer
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 is a
synthetic leucine amino acid analogue. Preliminary studies demonstrated efficacy in
primary prostate cancer and metastatic/recurrent prostate cancers. We propose to
evaluate GE-148 (18F) Injection as a PET radiopharmaceutical for the detection of
prostate cancer.
Objectives: Primary Objective:
- To differentiate the magnitude of uptake and retention of GE-148 (18F) Injection
between malignant prostate tumors, non-malignant prostate pathology, and regions of
normal prostate tissue in subjects with prostate cancer.
- To assess the safety of a single dose of GE-148 (18F) Injection in subjects with
prostate cancer.
Secondary Objectives:
- To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection
with quantitative assessment of AAT expression in malignant prostate tumors,
non-malignant prostate pathology, and regions of normal prostate tissue.
- To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection
with quantitative assessment of Ki-67 expression in malignant prostate tumors,
non-malignant prostate pathology, and regions of normal prostate tissue.
- To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection in
malignant prostate tumors and their Gleason Score.
- To assess the ability of GE-148 (18F) Injection to detect the number of discrete
malignant prostate tumors confirmed by histopathology.
- To assess the relationship between the magnitude of uptake of GE-148 (18F) Injection
with quantitative measurement of AAT and Ki-67 expression in pelvic lymph nodes showing
uptake of GE-148 (18F) Injection, where available.
- To compare the ability of PET/CT imaging with GE-148 (18F) Injection to predict
prostate malignancy and distinguish it from other pathologies (inflammation,
hyperplasia, atrophy, hemorrhage) with that of T2W MRI, DCE MRI, MR DWI, and MRSI
performed at 3T.
Eligibility:
- Subject is 18 years old, ECOG 0-2, with documented prostate cancer (minimum 1 core).
- Subject must be scheduled to undergo standard of care prostatectomy at NIH CC
Serum creatinine within 2 weeks prior to MRI less than or equal to1.8mg/dl, estimated
GFR(eGFR) must be greater than 30 ml/min/1.73m2.
-Chemistry parameters: Aspartate aminotransferase (AST), Alanine transferase (ALT)2 x of the
upper limits of normal; total bilirubin, of less than 2 x the upper limits of normal or less
than 3.0 mg/dl in patients with Gilbert's syndrome.
Design:
Thirty subjects with localized prostate cancer scheduled for prostatectomy will undergo
dynamic GE-148 (18F) Injection PET/CT imaging, and undergo a standard-of-care endorectal
coil/pelvic multiparametric MRI . Results will be compared with pathology.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Bio-distribution
2 years
No
Paul Gordon, PhD
Study Director
GE Healthcare
United States: Food and Drug Administration
GE-148-002
NCT01176513
July 2010
March 2012
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |