Clinical trial · Interventional
Imaging and Biomarkers of Hypoxia in Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Logistical
Summary
Brief summary (as posted)
Hypoxia, meaning a lack of oxygen, has been associated strongly with a wide range of human cancers. Hypoxia occurs when tumor growth exceeds the ability of blood vessels to supply the tumor with oxygenated blood. It is currently understood that hypoxic tumors are more aggressive. Current methods for measuring hypoxia include invasive procedures such as tissue biopsy, or insertion of an electrode into the tumor. EF5-PET may be a non-invasive way to measure tumor hypoxia.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbogen | Drug | — | UNRESOLVED |
| Dichloroacetate | Drug | — | UNRESOLVED |
| EF5 | Drug | — | UNRESOLVED |
| PET Scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carbogen arm
- interventionNames
- Procedure: PET Scan
- Drug: EF5
- Drug: Carbogen
- type
- EXPERIMENTAL
- label
- DCA arm
- interventionNames
- Procedure: PET Scan
- Drug: EF5
- Drug: Dichloroacetate
Primary outcomes (2)
- measure
- 18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.
- timeFrame
- 1-5 days
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * Any solid tumor malignancies of any stage meeting all of the following criteria: Minimum tumor dimension is at least 1 cm (to ensure it is above the detection threshold of PET imaging). Examples include but are not limited to: locally advanced squamous cell carcinoma of the head and neck to be treated by either initial surgery or primary chemoradiotherapy; inoperable non-small cell lung cancer or pancreatic carcinoma to be treated with stereotactic radiotherapy, which may be biopsied again at the time of percutaneous needle delivery of implanted fiducial markers. * Patients with newly diagnosed malignancies should not have initiated treatment for their disease before participating in this study. Patients with recurrent or second malignancies may have had prior therapy as appropriate for their disease, but should have completed all prior treatment at least 30 days before participation in this study and should not have initiated new treatment for the current problem. * Greater than or equal to eighteen years of age. * Sufficiently healthy to tolerate all study procedures. * Organ and marrow function sufficient to undergo planned therapy. * Ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA • Pregnant or nursing
References
Publications (0)
Data not yet available