Functional and Molecular Characterization of Treatment Response in Tumors in the Oral Cavity Using Optical Spectroscopy
- Conditions
- Head and Neck Cancer
- Interventions
- Device: Optical Spectroscopy
- Registration Number
- NCT04272294
- Lead Sponsor
- University of Arkansas
- Brief Summary
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.
- Detailed Description
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.
This study is a single-arm, single-center observational pilot study of the accuracy of DRS+RS at distinguishing early between treatment-resistant and treatment-responsive disease in study-eligible subjects undergoing first-line chemoradiation therapy for Stage 3 or 4 HNSCC of the larynx or tonsil.
Three (3) optical spectra each will be collected from the tumor, an adjacent normal site, and a normal tissue site on the buccal mucosa prior to treatment. The subject will undergo 4 repeat post-treatment measures taken after radiation therapy begins (marked as Day 1). Repeat measures will be taken on Day 2(+1), Day 4(±1), Day 7(±1), and Day 10(±1). The probe will be performed at the beginning of the radiation therapy visit, prior to the radiation dose that day.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Use of Optical Spectroscopy Optical Spectroscopy Optical spectroscopy used to characterize treatment response
- Primary Outcome Measures
Name Time Method Successful identification of treatment-resistant disease 3 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States