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

Phase 1

Terminated

• Conditions: Recurrent Glioblastoma
• Interventions: Biological: [18F]fluoromisonidazole; Drug: Bevacizumab; Radiation: positron emission tomography (PET/CT).

• Registration Number: NCT03573986
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-04-18
• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-06-29
• Primary Completion: 2020-01-14
• Study Completion: 2020-01-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Bevacizumab	-
Arm A	[18F]fluoromisonidazole	-
Arm A	positron emission tomography (PET/CT).	-

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States