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Device
Optoacoustic Tomography for Head and Neck Cancer (OUSCCMOTORX Trial)
N/A
Waitlist Available
Led By Christina Henson, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinically confirmed node positive head and neck squamous cell cancer
At least 18 years-of-age at the time of signature of the informed consent form (ICF)
Must not have
History of previous head and neck radiotherapy
Intent of treatment palliative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study a new device called Multispectral Optoacoustic Tomography (MSOT) to see if it can accurately detect and evaluate lymph nodes in the neck that may be affected
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since MSOT is an imaging technique and not a drug, side effects might be minimal or related to the procedure itself rather than systemic reactions like those seen with medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer in the head or neck area has spread to my lymph nodes.
Select...
I am 18 years old or older.
Select...
My treatment is aimed at curing my disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiotherapy for head or neck cancer before.
Select...
My treatment is aimed at easing symptoms, not curing the disease.
Select...
I am currently pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse events due to MSOT imaging after the completion of radiotherapy treatment.
Adverse events due to MSOT imaging during week 4 of radiotherapy
Adverse events due to MSOT imaging prior to radiotherapy
+3 moreSecondary study objectives
Assessment of radiation induced fibrosis via MSOT imaging in first follow up scan for Arm 2
Assessment of radiation induced fibrosis via MSOT imaging in fourth follow up scan for Arm 2
Assessment of radiation induced fibrosis via MSOT imaging in second follow up scan for Arm 2
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multispectral Optoacoustic Tomography
2018
N/A
~30
Temperature Measurement
2020
N/A
~60
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
468 Previous Clinical Trials
92,413 Total Patients Enrolled
Christina Henson, MDPrincipal InvestigatorUniversity of Oklahoma
3 Previous Clinical Trials
3,523 Total Patients Enrolled
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