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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

Primary Purpose

Recurrent Glioblastoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]fluoromisonidazole
Bevacizumab
positron emission tomography (PET/CT).
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Recurrent Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

Outcomes

Primary Outcome Measures

Number of Adverse Events

Secondary Outcome Measures

Full Information

First Posted
June 20, 2018
Last Updated
February 13, 2020
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03573986
Brief Title
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
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
January 14, 2020 (Actual)
Study Completion Date
January 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
[18F]fluoromisonidazole
Other Intervention Name(s)
18F-FMISO
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab (Avastin, Genentech/Roche) is a humanized monoclonal antibody that binds to VEGF preventing its interaction with VEGFRs resulting in suppression of VEGF signaling.
Intervention Type
Radiation
Intervention Name(s)
positron emission tomography (PET/CT).
Intervention Description
PET-CT Scan 1.) before start of Bevacizumab up to approximately 4 weeks and 2.) within 12-22 days of start of Bevacizumab
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyed Ali Nabavizadeh, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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