Clinical trial · Interventional
Assessment of Head and Neck Tumor Hypoxia Using 18F-Fluoromisonidazole
NCT00038038CI-TRIAL-00007686withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants enrolled, study terminated.
Summary
Brief summary (as posted)
The purpose of this clinical research study is to answer the following questions using 18F-fluoromisonidazole as an imaging agent: 1. Do cells exist in human tumors that are at very low oxygen levels (hypoxic cells)? 2. If hypoxic cells exist in human tumors, do they effect the ability of radiotherapy to control human tumors? 3. Can Positron Emission Tomography (PET scanning) detect hypoxic cells in human tumors?
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastases, Neoplasm | Head and Neck Squamous Cell Carcinoma | PROBABILISTIC | 0.70 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-fluoromisonidazole | Drug | — | UNRESOLVED |
| PET scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET + 18F-fluoromisonidazole
- interventionNames
- Drug: 18F-fluoromisonidazole
- Procedure: PET scan
Primary outcomes (1)
- measure
- Direct Oxygen Measurements
- timeFrame
- PET scan and needle measurements will be repeated every 4 weeks into the course of radiotherapy and again after the completion of radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven squamous cell carcinoma of head and neck wth metastatic neck nodes greater than or equal to 2cm * Karnofsky performance status greater or equal to 60% Exclusion Criteria: * No prior irradiation or surgery to head/neck area * No prior chemotherapy within 1 month of participation and have recovered from associated related effects * Not pregnant * Any intercurrent medical or physiologic disorder which would prevent informed consent * Underlying medical problems which would compromise technical ability to deliver a "standard course" of radiation therapy * Patients with PT or PTT over 1.5 times normal
References
Publications (0)
Data not yet available
No reference posted for this study.