GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer

NCT01176513 | Terminated Phase 2 Results

• 2 other identifiers: GE-148-00210-C-0179
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Prostate Cancer

Keywords

Prostate Cancer; MRI; PET; GE-148 (18F)

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  After GE-148 (18F) Injection administration.

Secondary Outcomes (1)

• 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.

  After GE-148 (18F) Injection administration

Study Arms (1)

GE 148-002

EXPERIMENTAL

Drug: GE-148 (18F)

Interventions

GE-148 (18F) DRUG

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.

Also known as: GE-148 (18F) Injection

GE 148-002

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)).

Sponsors & Collaborators

• GE Healthcare: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Jung JA, Coakley FV, Vigneron DB, Swanson MG, Qayyum A, Weinberg V, Jones KD, Carroll PR, Kurhanewicz J. Prostate depiction at endorectal MR spectroscopic imaging: investigation of a standardized evaluation system. Radiology. 2004 Dec;233(3):701-8. doi: 10.1148/radiol.2333030672.

  PMID: 15564406 BACKGROUND

• Swindle P, Eastham JA, Ohori M, Kattan MW, Wheeler T, Maru N, Slawin K, Scardino PT. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol. 2005 Sep;174(3):903-7. doi: 10.1097/01.ju.0000169475.00949.78.

  PMID: 16093984 BACKGROUND

• el-Gabry EA, Halpern EJ, Strup SE, Gomella LG. Imaging prostate cancer: current and future applications. Oncology (Williston Park). 2001 Mar;15(3):325-36; discussion 339-42.

  PMID: 11301831 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Paul Gordon, PhD
• Organization: GE Healthcare

Paul.Gordon@ge.com

011-47-2318-5822

Study Officials

• Paul Gordon, PhD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 14, 2014
• Results First Posted: November 21, 2013

Record last verified: 2014-01

Locations

US (1)