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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-06045 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 48917 | Other Identifier | Roswell Park Cancer Institute | |
| P30CA016056 | U.S. NIH Grant/Contract | View source | |
| R01CA204636 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. This study may help doctors determine if PAI is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). If there is a correlation with clinical responses, then doctors may develop PAI as method for measuring response to earlier treatment.
PRIMARY OBJECTIVE:
I. Define the feasibility of the current photoacoustic imaging (PAI) technology in head and neck (H&N) cancer patients.
SECONDARY OBJECTIVE:
I. Define the utility of the current PAI in H&N cancer patients.
OUTLINE:
PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy.
PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (PAI, ALTENS) | Experimental | PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy. PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photoacoustic Imaging | Procedure | Undergo PAI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate | Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image. | Up to 6 months after treatment completion |
| Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate | Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Utility of serial PAI-based oxygen saturation (%sO2) measurements | Descriptive statistics (means, medium) will be used to summarize percent of SO2 | Up to 2 years |
| Changes in hemoglobin (hbt) measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anurag K Singh | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Transcutaneous Acupoint Electrical Stimulation |
| Procedure |
Undergo ALTENS |
|
|
Compare hemoglobin measurements between baseline until end of study
| Up to 2 years |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D010039 | Otorhinolaryngologic Neoplasms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
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