Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-20
Brief Title:
Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Multispectral Optoacoustic Tomography for the Detection of Extranodal Extension and Radiation Induced Fibrosis in Head and Neck Squamous Cell Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OUSCCMOTORX
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
Detailed Description:
This is a 2-Arm investigational device study designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting and to determine the ability of MSOT imaging data to correlate with clinical findings identified via pathology Imaging with the MSOT device is expected to obtain information about the number size and appearance of the lymph nodes in the neck The device will be used to obtain images of the tumor or lymph node margins for investigational use only to compare to clinical pathology and patients medical records All images will be obtained pre-surgery for Arm 1 patients undergoing surgery for their cancer and before during and after radiotherapy in Arm 2 patients undergoing radiotherapy treatment for their cancer The temperature of the patients skin will also be measured prior to and after each MSOT scan Once radiotherapy treatment has completed images using the MSOT device will be obtained every 6 months for 2 years to assess for radiation induced fibrosis MSOT scans will be for research only and no treatment decisions will be based on the MSOT images obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None