Using a new imaging device to assess lymph nodes in head and neck cancer
Multispectral Optoacoustic Tomography for the Detection of Extranodal Extension and Radiation Induced Fibrosis in Head and Neck Squamous Cell Cancer
NA · University of Oklahoma · NCT06477003
This study is testing a new imaging device to see if it can safely and accurately identify lymph nodes affected by head and neck cancer in patients undergoing surgery or radiation treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT06477003 on ClinicalTrials.gov |
What this trial studies
This research evaluates the safety and effectiveness of the Multispectral Optoacoustic Tomography (MSOT) device in identifying and assessing lymph nodes affected by metastatic head and neck squamous cell carcinoma. The study involves two arms: one for patients undergoing surgery and another for those receiving radiotherapy. MSOT imaging will be conducted pre-surgery and at various intervals during and after treatment to gather data on lymph node characteristics and monitor for radiation-induced changes. The findings will be compared to clinical pathology results to determine the device's accuracy and utility.
Who should consider this trial
Good fit: Ideal candidates include adults with clinically confirmed node-positive head and neck squamous cell carcinoma who are planned for curative intent therapy.
Not a fit: Patients with a history of previous head and neck radiotherapy or those receiving palliative treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more precise imaging techniques for better management of head and neck cancer.
How similar studies have performed: While the use of optoacoustic imaging is relatively novel, similar imaging techniques have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Christina Henson, MD — University of Oklahoma
- Study coordinator: Ingrid Block
- Email: SCC-IIT-Office@ouhsc.edu
- Phone: 1-405-271-8777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Squamous Cell Carcinoma, Imaging device