GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer
| Status: | Archived |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2010 |
| End Date: | July 2012 |
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:
- 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 prostate cancer lesions to appear more clearly on imaging scans. Researchers are
also interested in determining whether the combination can help make cancer cells in pelvic
lymph nodes easier to detect through imaging studies. GE-148 (18F) will be used to examine
individuals who are scheduled to have surgery on their prostate cancer.
Objectives:
- To evaluate the effectiveness of GE-148 (18F) in detecting prostate cancer and cancer
cells in pelvic lymph nodes using positron emission tomography and magnetic resonance
imaging scanning.
Eligibility:
- Men at least 18 years of age who have been diagnosed with prostate cancer and are
scheduled to have prostate removal surgery.
Design:
- Participants will be screened with a physical examination, medical history, blood
tests, and imaging studies.
- Participants will have magnetic resonance imaging (MRI) and positron emission
tomography (PET) scans with GE-148 (18F) prior to their scheduled surgery. The MRI and
PET scans may be performed on the same day or on different days, depending on the
schedule set by the study researchers.
- Tissue samples taken during prostate removal surgery, including prostate tissue and
pelvic lymph nodes, will be collected for further study of the effectiveness of GE-148
(18F).
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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