Clinical trial · Interventional
Tumor Hypoxia and Proliferation in Patients With High-Grade Glioma
A Phase-I Trial for Simultaneous Imaging of Tumor Hypoxia and Proliferation in Patients With Treatment- Naïve High-Grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study team would like to implement an amendment to the protocol with the corresponding IRB before continuing with recruitment.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FLT PET | Drug | — | UNRESOLVED |
| 18F-FMISO PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High Grade Glioma (HGG)
- description
- Thirty newly diagnosed treatment-naïve subjects with suspected HGG based on clinical presentation and MRI findings and undergoing surgical planning will be accrued in this study.
- interventionNames
- Drug: 18F-FMISO PET
- Drug: 18F-FLT PET
Primary outcomes (2)
- measure
- Quantitation of tumor hypoxia (FMISO) by measuring Dyn PET
- timeFrame
- 1 year
- description
- Simultaneous quantitation of tumor hypoxia (FMISO): Dyn-PET data will be acquired with staggered FMISO/FLT injections and then the two radiotracer signals will be deconvolved using our novel pharmacokinetics modeling approach (Sections D2, D3, and D4 of Preliminary Data)
- measure
- Quantitation of proliferation (FLT) by measuring Dyn PET
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ≥ 18 years of age * Documentation of a suspected HGG diagnosis based on clinical and MRI findings Exclusion Criteria: * Pregnant or breastfeeding * Contraindications to receiving Positron Emission Tomography (PET) imaging (e.g. claustrophobia)
References
Publications (0)
Data not yet available