Clinical trial · Interventional
Optical Imaging of Head and Neck Cancer
In Vivo Multimodal Imaging of Upper Aerodigestive Epithelia
NCT01456143CI-TRIAL-00031488terminatedN/AResults postedClinicalTrials.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): PI left, study to be re-open with new PI, no planned data analysis
Summary
Brief summary (as posted)
This study examines if certain imaging techniques and devices can aid the surgeon in detecting cancer during the surgical procedure.
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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Neoplasia | Neoplasm | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Resolution Microendoscopy (HRME) | Device | — | UNRESOLVED |
| Proflavine hemisulfate | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRME with proflavine
- description
- High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
- interventionNames
- Device: High Resolution Microendoscopy (HRME)
- Other: Proflavine hemisulfate
Primary outcomes (6)
- measure
- Accuracy
- timeFrame
- Immediately following image (day of enrollment or up to 2 weeks after enrollment)
- description
- Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results
- measure
- Sensitivity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy Proven Squamous Cell Carcinoma of the oral cavity, oropharynx, larynx, hypopharynx * Must be receiving surgical treatment for their cancer Exclusion Criteria: * Presence of medical or psychiatric condition affecting the ability to give informed consent * Known allergy to Proflavin * Pregnant or nursing Females
References
Publications (0)
Data not yet available
No reference posted for this study.