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Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab

18 Years
Not Enrolling
Glioblastoma Multiforme (GBM)

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Trial Information

Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab

Inclusion Criteria:

- Patients must be 18 years or older for inclusion in this research study. There is
inadequate experience with the safety of [18F] Fluciclatide (GE [18F]AH111585) in
children and therefore this radiopharmaceutical should not be used in patients under
the age of 18.

- The patient must have a histologically proven GBM, and are scheduled to be treated
with Avastin therapy.

- Patient has a tumor volume of > 2.0 cm in greatest diameter is required to assess
response to therapy.

- An anatomic imaging study (MRI of the brain) must be current and have been obtained
within 28 days prior to the research PET imaging studies.

- Patients must agree to have clinical and radiographic endpoints and the results of
histopathologic tissue analysis and other laboratory information entered into a
research database, as evidenced by signing the informed consent form.

- All patients, or their legal guardians, must sign a written informed consent and
HIPAA authorization in accordance with institutional guidelines.

- If patient is female, she must be postmenopausal for a minimum of one year,
surgically sterile, or has been confirmed not to be pregnant by serum pregnancy test
performed within 48 hours prior to research PET imaging.

- Patient must not be lactating.

- Pre-treatment laboratory tests for patients receiving [18F] Fluciclatide (GE
[18F]AH111585) must be performed within 21 days prior to study entry.

- These laboratory tests must be less than 4.0 times below or above the upper or
lower limit range for the respective laboratory test for entry into the study
(unless not medically or clinically relevant).

- For those patients receiving coumadin or another anticoagulant the upper limit
for prothrombin time or partial thromboplastin time must not exceed 6 times the
upper limit of the normal range.

- Urinalysis abnormalities will not preclude the patient from being enrolled and

- The laboratory testing will include liver enzymes (SGOT, SGPT, ALK Phos, GGT,
LDH), bilirubin (total), amylase, albumin, serum electrolytes (sodium,
potassium, chloride, HCO3, calcium, creatinine, urea nitrogen, glucose) CBC with
platelets prothrombin time, partial thromboplastin time, BUN, creatinine and
urinalysis (screening only).

Exclusion Criteria:

- Patients with known allergic or hypersensitivity reactions to previously administered
radiopharmaceuticals. Patients with significant drug or other allergies or
autoimmune diseases may be enrolled at the Investigator's discretion.

- Adult patients who require monitored anesthesia for PET scanning.

- Patients who are too claustrophobic to undergo MRI or PET imaging.

- Patients with a calculated GFR of less than 30 ml/min will be excluded from the
study. For a GFR between 30-60 ml/min the MRI will be possible (using half the usual
administered dose of contrast) at the discretion of the study doctor. If the patient
does not wish to undergo an MRI due to their renal function they will be excluded
from the study.

- Patients known to be HIV positive. This is due to the unknown potential toxicities of
Fluciclatide in HIV positive patients.

- Patients who cannot undergo MRI imaging due to MRI exclusion criteria

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Description:

The first exploratory hypothesis to be tested is that increased [18F] Fluciclatide uptake at baseline imaging may be correlated with a shorter time to progression.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

John Hoffman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2013

Completion Date:

April 2016

Related Keywords:

  • Glioblastoma Multiforme (GBM)
  • Glioblastoma



Huntsman Cancer Institute Salt Lake City, Utah  84112