GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer
- 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.
- 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.
- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have prostate removal surgery.
- 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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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|
- To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging. [ Time Frame: After GE-148 (18F) Injection administration. ] [ Designated as safety issue: No ]Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.
- 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. [ Time Frame: After GE-148 (18F) Injection administration ] [ Designated as safety issue: No ]Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.
|Study Start Date:||July 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: GE 148-002||
Drug: GE-148 (18F)
All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Other Name: GE-148 (18F) Injection
- 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.
- 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.
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176513
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Study Director:||Paul Gordon, PhD||GE Healthcare|