Functional and Molecular Characterization of Treatment Response in Tumors in the Oral Cavity Using Optical Spectroscopy

NCT ID: NCT04272294

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-22
• Study Completion Date: 2024-11-22

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Use of Optical Spectroscopy

Optical spectroscopy used to characterize treatment response

Group Type: EXPERIMENTAL

Optical Spectroscopy

Intervention Type: DEVICE

Using oral spectroscopy device to characterize treatment response in tumors

Interventions

Optical Spectroscopy

Using oral spectroscopy device to characterize treatment response in tumors

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moreno Mauricio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

239327

Identifier Type: -

Identifier Source: org_study_id