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

NCT04272294 | Withdrawn DMC FDA Device

• 1 other identifier: 239327
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Successful identification of treatment-resistant disease

  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.

  3 weeks

Study Arms (1)

Use of Optical Spectroscopy

EXPERIMENTAL

Optical spectroscopy used to characterize treatment response

Device: Optical Spectroscopy

Interventions

Optical Spectroscopy DEVICE

Using oral spectroscopy device to characterize treatment response in tumors

Use of Optical Spectroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Spectrum Analysis, Raman

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Scattering, Radiation; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis

Study Officials

• Moreno Mauricio, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: November 22, 2024
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)