Diagnosis and Risk Assessment of Locally Advanced Rectal Cancer Using Co-registered Ultrasound and Photoacoustic Imaging

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to demonstrate the functionality of a novel endorectal photoacoustic ultrasound imaging modality in humans with rectal cancer. The study involves testing a previously developed endorectal device to determine its ability to accurately assess rectal tumor response to preoperative treatment. Investigators hypothesize that a co-registered photoacoustic ultrasound endorectal device can significantly reduce unnecessary surgeries in rectal cancer patients with complete clinical response while maintaining high sensitivity in identifying those with residual cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Patients with any stage of rectal cancer undergoing surgical resection and the 3 surgeons and 1 radiologist as part of the reader team who diagnose the images obtained in these patients using the PAM/US probe.

• Age \>18 years

• Able to provide informed consent

⁃ Additional Inclusion Criterion for in vivo imaging

• In patients: Lesion located within 15cm of the anal verge

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
William Chapman, Jr., M.D.
chapmanjr@wustl.edu
314-454-7177
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 90
Treatments
Other: In vivo imaging
* Patients with distal rectal lesions (benign or malignant tumors within 15cm of the anal verge) will be enrolled for the in vivo imaging portion of the study~* Participation will include an intraoperative, in vivo evaluation of the tumor with a novel endorectal photoacoustic ultrasound probe. Following the induction of anesthesia, patients will undergo a 20-minute endorectal imaging evaluation performed by their colorectal surgeon. After imaging, the patient will then undergo standard-of-care surgical resection of the rectum. The resection specimen may then be imaged ex vivo as deemed necessary.~* For this portion of the study, enrollment will be limited to a total of 86 participants
Experimental: Reader Team
3 surgeons and 1 radiologist will be initially trained to grade lesions using the PAM/US image from the first set of 30 patients (Group 1). They will then use the PAM/US images and machine learning model to grade lesions on the images obtained from the second set of 56 patients (Group 2).
Authors
Deyali Chatterjee, Matthew Mutch
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials