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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04110249
Other study ID # I 48917
Secondary ID NCI-2019-06045I
Status Terminated
Phase N/A
First received
Last updated
Start date September 6, 2019
Est. completion date December 29, 2022

Study information

Verified date April 2023
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date December 29, 2022
Est. primary completion date December 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - No restriction on race or ethnic background - Subject must understand the investigational nature of the study and sign an independent ethics committee/institutional review board approved written informed consent prior to receiving any study related procedure - FOR CANCER PATIENTS IN THE H&N RADIATION GROUP (PART I): - Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) getting chemoradiation therapy - Presence of neck nodes or laryngeal tumor superficial enough (within 2-3 cm of skin surface) to allow imaging by photoacoustic ultrasound (PA-US) - FOR ALTENS PATIENTS (PART II): - History of prior radiation therapy with xerostomia requiring ALTENS Exclusion Criteria: - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Unwilling or unable to follow protocol requirements or provide consent - Any condition which in the Investigator?s opinion deems the subject an unsuitable candidate to undergo imaging procedure

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Photoacoustic Imaging
Undergo PAI
Transcutaneous Acupoint Electrical Stimulation
Undergo ALTENS

Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
Roswell Park Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary Changes in hemoglobin (hbt) measurements Compare hemoglobin measurements between baseline until end of study Up to 2 years
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