Clinical trial · Interventional
MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer
Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI
NCT00896350CI-TRIAL-00037141terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment. PURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck 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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Care Chemoradiation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BOLD MRI
- description
- Determine the amount of oxygen supply to tumors.
- interventionNames
- Drug: Standard Care Chemoradiation
Primary outcomes (2)
- measure
- MRI signal sensitivity to oxygen
- timeFrame
- 12 weeks
- description
- MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)
- measure
- Tumor shrinkage and blood oxygen association
- timeFrame
- 12 weeks
- description
- Association between tumor shrinkage and blood oxygen level dependent
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Stage III or IV disease * Measurable disease * Scheduled to undergo standard treatment including radiation therapy and chemotherapy * Participation on study # 092004-010 for tissue procurement PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Serum creatinine ≤ 1.5 OR creatinine clearance ≥ 40 * Body mass index ≤ 34 Kg/m\^2 * Not claustrophobic * No other contraindications to MRI (i.e., implanted pacemaker device) * Not pregnant or nursing * Negative pregnancy test * No allergy to gadolinium PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.