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

Studies

Study First Submitted Date 2020-02-13
Study First Posted Date 2020-02-17
Last Update Posted Date 2023-02-28
Start Month Year March 2024
Primary Completion Month Year October 2025
Verification Month Year February 2023
Verification Date 2023-02-28
Last Update Posted Date 2023-02-28

Detailed Descriptions

Sequence: 20742515
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.

Facilities

Sequence: 200287737
Name University of Arkansas for Medical Sciences
City Little Rock
State Arkansas
Zip 72205
Country United States

Facility Contacts

Sequence: 28134663 Sequence: 28134664
Facility Id 200287737 Facility Id 200287737
Contact Type primary Contact Type backup
Name Aaron Holley Name Beth Scanlan
Email jaholley@uams.edu Email bscanlan@uams.edu
Phone 501-686-8274 Phone 501-686-8274

Facility Investigators

Sequence: 18347173
Facility Id 200287737
Role Principal Investigator
Name Mauricio Moreno, MD

Conditions

Sequence: 52224796
Name Head and Neck Cancer
Downcase Name head and neck cancer

Id Information

Sequence: 40197950
Id Source org_study_id
Id Value 239327

Countries

Sequence: 42611913
Name United States
Removed False

Design Groups

Sequence: 55653483
Group Type Experimental
Title Use of Optical Spectroscopy
Description Optical spectroscopy used to characterize treatment response

Interventions

Sequence: 52538505
Intervention Type Device
Name Optical Spectroscopy
Description Using oral spectroscopy device to characterize treatment response in tumors

Design Outcomes

Sequence: 177573632
Outcome Type primary
Measure Successful identification of treatment-resistant disease
Time Frame 3 weeks
Description 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.

Browse Conditions

Sequence: 193691123 Sequence: 193691124 Sequence: 193691125
Mesh Term Head and Neck Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms
Downcase Mesh Term head and neck neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48369558
Agency Class OTHER
Lead Or Collaborator lead
Name University of Arkansas

Overall Officials

Sequence: 29314634
Role Principal Investigator
Name Moreno Mauricio, MD
Affiliation University of Arkansas

Central Contacts

Sequence: 12021408 Sequence: 12021409
Contact Type primary Contact Type backup
Name Aaron Holley Name Beth Scanlan
Phone 501-686-8274 Phone 501-686-8274
Email jaholley@uams.edu Email bscanlan@uams.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68221758
Design Group Id 55653483
Intervention Id 52538505

Eligibilities

Sequence: 30796644
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254007307
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30542679
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Diagnostic
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28908999
Responsible Party Type Sponsor