Optoacoustic Tomography for Head and Neck Cancer
(OUSCCMOTORX Trial)

Recruiting in Palo Alto (17 mi)

Overseen byChristina Henson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Oklahoma

Disqualifiers: Previous radiotherapy, Pregnant, Others

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research is to assess the safety and evaluate the potential of the Multispectral Optoacoustic Tomography (MSOT) device to more precisely identify and assess the neck lymph nodes which might be affected in patients with metastatic head and neck squamous cell carcinomas.

Eligibility Criteria

This trial is for patients with metastatic head and neck squamous cell carcinomas. Specific eligibility criteria are not provided, but typically participants would need to have the condition under study and meet certain health requirements.

Inclusion Criteria

Written informed consent signed and dated by the patient prior to the performance of the MSOT

Patient available for the study duration

Patients of childbearing potential must use an effective form of contraceptive as per the protocol

+4 more

Exclusion Criteria

I have had radiotherapy for head or neck cancer before.

Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol

My treatment is aimed at easing symptoms, not curing the disease.

+2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Imaging (Arm 1)

MSOT imaging is performed on patients prior to surgery to assess lymph nodes and tumor margins.

1 day

1 visit (in-person)

Radiotherapy Imaging (Arm 2)

MSOT imaging is performed before, during, and after radiotherapy to assess lymph nodes and tumor margins.

6-8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for radiation induced fibrosis using MSOT imaging every 6 months for 2 years.

24 months

4 visits (in-person)

Participant Groups

The trial is testing Multispectral Optoacoustic Tomography (MSOT), a device that may help identify affected neck lymph nodes more accurately in these cancer patients. Temperature measurement is also part of the intervention being studied.

2Treatment groups

Experimental Treatment

Group I: Arm 2 - radiotherapy patientsExperimental Treatment2 Interventions

30 patients with clinically confirmed metastatic head and neck squamous cell carcinomas (N+ HNSCC) planned for definitive radiotherapy (RT) (+/- chemo) will be imaged using the MSOT device before, during, and after radiotherapy. 15 patients will be treated with photon RT and 15 patients will be treated with proton therapy. Skin temperature will be measured prior to and after MSOT imaging to assess for safety.

Group II: Arm 1 - surgery patientsExperimental Treatment2 Interventions

70 patients with clinically confirmed metastatic head and neck squamous cell carcinomas (N+ HNSCC) planned for definitive surgery will be imaged using the MSOT device prior to surgery. Skin temperature will be measured prior to and after MSOT imaging to assess for safety.