Status:
RECRUITING
Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Rectal Cancer
Colorectal Cancer
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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 deve...
Detailed Description
The investigators hypothesize that a co-registered photoacoustic ultrasound endorectal device can significantly reduce unnecessary surgeries in rectal cancer patients with complete clinical response w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- In patients: Inability to provide consent
- In patients: Collection of intraoperative specimen for frozen section analysis will disqualify patients from participation
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04339374
Start Date
May 1 2023
End Date
December 31 2028
Last Update
May 4 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110