Clinical Trial · NCT02431572

A Pilot Study to Evaluate PBR PET in Brain Tumor Patients Treated With Chemoradiation or Immunotherapy

Overview

This research study is studying the changes in primary and metastatic brain tumor inflammation using positron emission tomography (PET) imaging using a radioactive substance called \[11C\] PBR28a, which is also known as peripheral benzodiazepine receptors (PBR), or PBR-PET.

Sponsor

Massachusetts General Hospital

Phase

N/A

Contacts

Elizabeth Gerstner, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02431572

Drug / Compound

PBR28

Isotope(s):

Target(s):

TSPO

Ligand Class: Small Molecules

Eligibility

Inclusion

ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Age \> 18 years.
* Participants must have evidence of metastatic melanoma to the brain for Cohort A or histologically confirmed GBM for Cohorts Band C.
Participants must have measurable brain disease, defined as at least one lesion that is 10 mm in diameter.
Those with newly diagnosed GBM but suspected to have pseudoprogression after completion of chemoradiation can enroll in Cohort C.

Exclusion

Patients who are not suitable to undergo MRI or PET or use gadolinium contrast due to:
Pregnant women are excluded from this study because PBR is a radiopharmaceutical agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to exposure of the mother to PBR, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to PBR.
HIV-positive participants are excluded because their immune system is compromised and may affect the interpretation of the imaging data.