Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT04272294
Status:
WITHDRAWN
Last Update Posted:
2024-11-26
First Post:
2020-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional and Molecular Characterization of Treatment Response in Tumors in the Oral Cavity Using Optical Spectroscopy
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
Functional and Molecular Characterization of Treatment Response in Tumors in the Oral Cavity Using Optical Spectroscopy
Status:
WITHDRAWN
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: