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Tumor Hypoxia and Proliferation in Patients With High-Grade Glioma

NCT04309552 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-01-27

No results posted yet for this study

Summary

This is a pilot study to assess a new methodology developed for High Grade Glioma (HGG). FMISO PET (Fluoromisonidazole-PET) allows researchers to study whether tumor cells lack oxygen (hypoxia). FLT PET (Fluorodeoxythymidine-PET) allows researchers to study the increase in the number of cells as a result of cell growth and cell division (proliferation). Tumors that have low oxygen levels and/or are dividing fast shall resist to standard cancer treatment. The study will compare FMISO PET and FLT PET imaging techniques with molecular biomarkers of hypoxia, angiogenesis, and cellular proliferation in tissue. proliferation).This information could help researchers develop new treatment techniques to better treat cancer.

Conditions

Interventions

DRUG

18F-FMISO PET

Suspected HGG subjects will undergo combined FMISO/FLT dyn-PET at baseline as part of surgical planning. Dyn-PET images will be acquired with staggered FMISO/FLT injections using a lag time of 50 minutes. Preoperatively FMISO/FLT dyn-PET data will be used for intraoperative neuro-navigation and targeted sampling of PET avid tumor subregions prior to tumor excision. Paraffin blocks will be analyzed with immuno-histochemistry and in situ hybridization for HIF-1α, Ki-67, VEGF, EGFR, IDH, and pimonidazole, as well as TERT. FMISO-PET uptake rate, k3, (surrogate for hypoxia) and FLT-PET influx rate, Ki (surrogate for proliferation) will be correlated with time to progression, progression-free survival at 9 months, and overall survival (OS) at 1 year.

DRUG

18F-FLT PET

Suspected HGG subjects will undergo combined FMISO/FLT dyn-PET at baseline as part of surgical planning. Dyn-PET images will be acquired with staggered FMISO/FLT injections using a lag time of 50 minutes. Preoperatively FMISO/FLT dyn-PET data will be used for intraoperative neuro-navigation and targeted sampling of PET avid tumor subregions prior to tumor excision. Paraffin blocks will be analyzed with immuno-histochemistry and in situ hybridization for HIF-1α, Ki-67, VEGF, EGFR, IDH, and pimonidazole, as well as TERT. FMISO-PET uptake rate, k3, (surrogate for hypoxia) and FLT-PET influx rate, Ki (surrogate for proliferation) will be correlated with time to progression, progression-free survival at 9 months, and overall survival (OS) at 1 year.

Sponsors & Collaborators

  • William Rhodes Center for Glioblastoma

    collaborator UNKNOWN

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Sadek Nehmeh, PhD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309552 on ClinicalTrials.gov