Optoacoustic Tomography for Head and Neck Cancer

(OUSCCMOTORX Trial)

Overseen By Ingrid Block

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Previous radiotherapy, Pregnant, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

100 Participants Needed

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.

Research Team

Christina Henson, MD

Principal Investigator

University of Oklahoma

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

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.

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)

Treatment Details

Interventions

• Multispectral Optoacoustic Tomography

Trial Overview 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.

Participant Groups

Group I: Arm 2 - radiotherapy patients Experimental Treatment 2 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 patients Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+