Clinical trial · Interventional
Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer
A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): equipment issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Lymph Node | — | UNRESOLVED | — |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Laryngeal Neoplasm | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Radiation Therapy Recipient | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photoacoustic Imaging | Procedure | — | UNRESOLVED |
| Transcutaneous Acupoint Electrical Stimulation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (PAI, ALTENS)
- description
- 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.
- interventionNames
- Procedure: Photoacoustic Imaging
- Procedure: Transcutaneous Acupoint Electrical Stimulation
Primary outcomes (2)
- measure
- Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
- timeFrame
- Up to 6 months after treatment completion
- description
- Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available