NCT04339374 Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
| NCT ID | NCT04339374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2028-12-31 |
Trial Parameters
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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 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 Criteria
Inclusion Criteria Patients: * Patients with any stage of rectal cancer undergoing surgical resection. * Age \>18 years * Able to provide informed consent Additional Inclusion Criterion for in vivo imaging (patients): * Lesion located within 15cm of the anal verge Exclusion Criteria Patients: * Inability to provide consent * Collection of intraoperative specimen for frozen section analysis will disqualify patients from participation Eligibility Criteria Readers: * Colorectal surgeons or radiologists who treat or interpret imaging regularly for patients with rectal cancer.
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