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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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.

Inclusion Criteria


- 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)).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Bio-distribution

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Paul Gordon, PhD

Investigator Role:

Study Director

Investigator Affiliation:

GE Healthcare

Authority:

United States: Food and Drug Administration

Study ID:

GE-148-002

NCT ID:

NCT01176513

Start Date:

July 2010

Completion Date:

March 2012

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • MRI
  • PET
  • GE-148 (18F)
  • Prostatic Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892