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Pilot Study of 18F-FMISO PET/CT and MRI Imaging to Explore Tissue Hypoxia and Arteriovenous Shunting in Subjects With Recurrent Glioblastoma Before and After Bevacizumab Treatment

Study Purpose

Subjects with recurrent glioblastoma who are candidates for bevacizumab treatment according to standard of care will be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer [18F]FMISO to image the brain and evaluate for hypoxia pre and post therapy.. Subjects will also undergo up to three Brain MRIs.

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:

  • - Participants will be ≥ 18 years of age.
  • - Biopsy proven glioblastoma.
  • - Must meet one of the following criteria: - Recent surgery (within 2 months) showing recurrent glioblastoma with measurable (20 mm in 2 dimensions) residual tumor.
Radiologic evidence of recurrent tumor based on conventional and advanced MRI findings.
  • - Recommended for clinically indicated bevacizumab therapy.
  • - Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.
  • - Karnofsky performance status ≥ 60.
  • - Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

  • - Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
  • - Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
  • - Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
  • - Less than 3 months from finishing the most recent radiation or immunotherapy.
  • - Contraindications to MRI or use of gadolinium contrast.
  • - Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study.
Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must understand and be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Pregnant women, children, fetuses, neonates, or prisoners are not included in this research study.

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.

 NCT03573986
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 1
Lead Sponsor

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

 Abramson Cancer Center at Penn Medicine
Principal Investigator

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

 Seyed Ali Nabavizadeh, MD
Principal Investigator Affiliation Abramson Cancer Center at Penn Medicine
Agency Class

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

 Other
Overall Status Terminated
Countries United States
Conditions

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

 Recurrent Glioblastoma
Arms & Interventions

Arms

Experimental: Arm A

Interventions

Biological: - [18F]fluoromisonidazole

positron emitting radiopharmaceutical that has been studied in vivo in humans for measurement of regional hypoxia in a number of tumor types with positron emission tomography (PET/CT)

Drug: - Bevacizumab

Bevacizumab (Avastin, Genentech/Roche) is a humanized monoclonal antibody that binds to VEGF preventing its interaction with VEGFRs resulting in suppression of VEGF signaling.

Radiation: - positron emission tomography (PET/CT).

PET-CT Scan 1.) before start of Bevacizumab up to approximately 4 weeks and 2.) within 12-22 days of start of 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.

Philadelphia, Pennsylvania

Status

Address

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

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