Clinical trial · Interventional
Functional and Molecular Characterization of Treatment Response in Tumors in the Oral Cavity Using Optical Spectroscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study never initiated
Summary
Brief summary (as posted)
The objective of this pilot study is to estimate the sensitivity and specificity of diffuse reflectance spectroscopy (DRS) and Raman spectroscopy (RS) at detecting treatment-resistant disease when DRS and RS are used together to measure treatment-induced reoxygenation and molecular changes in tumors of the oral cavity. This study will be performed in a total of 90 patients that have Stage 3 or 4 head and neck squamous cell carcinoma (HNSCC) with primary tumors located in the larynx or one tonsil.
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 |
|---|---|---|---|
| Optical Spectroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Use of Optical Spectroscopy
- description
- Optical spectroscopy used to characterize treatment response
- interventionNames
- Device: Optical Spectroscopy
Primary outcomes (1)
- measure
- Successful identification of treatment-resistant disease
- timeFrame
- 3 weeks
- description
- a sensitivity estimate of 70%, i.e., successful identification of treatment-resistant disease in 70% of the patients who have it (as defined by RECIST v1.1) before Week 3 of treatment will constitute a benchmark of success.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and older * Diagnosis of stage 3 or 4 HNSCC with documentation of HPV status * Tumor located in one of the tonsils and/or larynx * Expected to have ability to tolerate laryngoscope procedure * Must sign Informed Consent Form * Scheduled for chemoradiation therapy Exclusion Criteria: * Previous oral cavity or tonsil or pharyngeal surgery or therapy related to the disease * Disease in both tonsils * Patients who, in opinion of Investigator, should not participate * Women who are pregnant or breastfeeding
References
Publications (0)
Data not yet available