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 |
| jaholley@uams.edu | 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 |
| jaholley@uams.edu | 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 |