Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-06

Study Completion Date

2022-12-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

NCT04428515

Head and Neck Cancer

RECRUITING

Photoacoustic Imaging of Head and Neck Tumours

NCT05073809

Head and Neck Cancer

WITHDRAWN

Protocol for Radiofrequency Ablation of Pulmonary Neoplasms

NCT00232128

Pulmonary Neoplasms

TERMINATED NA

MRG FU With Radiotherapy for Palliation of H&N Cancer

NCT03218475

Head and Neck Cancer

SUSPENDED NA

Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy

NCT05490875

Head and Neck Cancer Carotid Artery Stenosis Cardiovascular Complication

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Carcinoma Head and Neck Lymph Node Head and Neck Squamous Cell Carcinoma Laryngeal Neoplasm Radiation Therapy Recipient

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic (PAI, ALTENS)

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.

Group Type EXPERIMENTAL

Photoacoustic Imaging

Intervention Type PROCEDURE

Undergo PAI

Transcutaneous Acupoint Electrical Stimulation

Intervention Type PROCEDURE

Undergo ALTENS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Photoacoustic Imaging

Undergo PAI

Intervention Type PROCEDURE

Transcutaneous Acupoint Electrical Stimulation

Undergo ALTENS

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

acupuncture-like transcutaneous electrical nerve stimulation ALTENS TAES

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No