NCT06477003

Brief Summary

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Nov 2027

First Submitted

Initial submission to the registry

June 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

June 20, 2024

Last Update Submit

January 26, 2026

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Imaging device

Outcome Measures

Primary Outcomes (6)

  • Adverse events due to MSOT imaging prior to surgery

    Proportion of patients that experience adverse events resulting from MSOT imaging. The first MSOT image will be taken prior to surgery

    30 minutes for an MSOT image (up to 24 hours post-image)

  • Adverse events due to MSOT imaging prior to radiotherapy

    Proportion of patients that experience adverse events resulting from MSOT imaging. The first MSOT image will be taken prior to radiotherapy.

    30 minutes for an MSOT image (up to 24 hours post-image)

  • Adverse events due to MSOT imaging during week 4 of radiotherapy

    Proportion of patients that experience adverse events resulting from MSOT imaging. The second MSOT image will be taken during week 4 of radiotherapy for patients enrolled in Arm 2.

    30 minutes for an MSOT image (up to 24 hours post-image)

  • Adverse events due to MSOT imaging after the completion of radiotherapy treatment.

    Proportion of patients that experience adverse events resulting from MSOT imaging. The third MSOT image will be taken after conclusion of radiotherapy for patients enrolled in Arm 2.

    30 minutes for an MSOT image (up to 24 hours post-image)

  • Measurement of skin temperature before MSOT imaging

    Number of patients with skin temperatures measured pre-MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) before the MSOT image is obtained.

    1-2 minutes before the MSOT image.

  • Measurement of skin temperature after MSOT imaging

    Number of patients with skin temperatures measured post-MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) after the MSOT image is obtained.

    1-2 minutes after the MSOT image

Secondary Outcomes (5)

  • Assessment of radiation induced fibrosis via MSOT imaging in first follow up scan for Arm 2

    30 minutes for an MSOT image (up to 24 hours post-image)

  • Assessment of radiation induced fibrosis via MSOT imaging in second follow up scan for Arm 2

    30 minutes for an MSOT image (up to 24 hours post-image)

  • Assessment of radiation induced fibrosis via MSOT imaging in third follow up scan for Arm 2

    30 minutes for an MSOT image (up to 24 hours post-image)

  • Assessment of radiation induced fibrosis via MSOT imaging in fourth follow up scan for Arm 2

    30 minutes for an MSOT image (up to 24 hours post-image)

  • Degree of bias for the comparison of MSOT images with CT scans (or other imaging modalities if necessary)

    2 years

Study Arms (2)

Arm 1 - surgery patients

EXPERIMENTAL

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.

Device: Multispectral Optoacoustic TomographyProcedure: Temperature Measurement

Arm 2 - radiotherapy patients

EXPERIMENTAL

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.

Device: Multispectral Optoacoustic TomographyProcedure: Temperature Measurement

Interventions

Multispectral Optoacoustic TomographyDEVICE

The MSOT device will be used to take images of the tumor or affected lymph nodes of patients with head and neck squamous cell carcinoma.

Arm 1 - surgery patientsArm 2 - radiotherapy patients
Temperature MeasurementPROCEDURE

The temperature of the skin will be measured prior to and after MSOT imaging.

Arm 1 - surgery patientsArm 2 - radiotherapy patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically confirmed node positive head and neck squamous cell cancer
  • Written informed consent signed and dated by the patient prior to the performance of the MSOT
  • At least 18 years-of-age at the time of signature of the informed consent form (ICF)
  • Patients planned for curative intent therapy
  • Patient available for the study duration
  • Patients of childbearing potential must have a negative pregnancy test prior to the study entry.
  • Patients of childbearing potential must use an effective form of contraceptive as per the protocol.

You may not qualify if:

  • History of previous head and neck radiotherapy
  • Intent of treatment palliative
  • Women who are pregnant
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of the investigational regimen should be included.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Christina Henson, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2024

First Posted

June 27, 2024

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)