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

Study Purpose

This exploratory study uses [18F] Fluciclatide and Positron emission tomography (PET) imaging in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab. The primary objective of this study is to determine the association of [18F] Fluciclatide uptake, fludeoxyglucose (FDG) uptake, and tumor blood flow/perfusion determined with H215O and Magnetic resonance imaging (MRI) and correlate these variables with time to progression (TTP) in participants with GBM treated with Bevacizumab.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 studied.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01788280
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Utah
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

John Hoffman, MD
Principal Investigator Affiliation Huntsman Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme (GBM)
Arms & Interventions

Arms

Experimental: All participants

All enrolled participants

Interventions

Drug: - Fluciclitite , PET imaging, and Bevacizumab

[18F] Fluciclatide and PET imaging in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112