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Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer

Recruiting

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

Who can join

Ages 19 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Washington University School of Medicine · Participants: 90 · Started: May 1, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT04339374

Locations in the U.S.

MissouriWashington University School of Medicine, St Louis

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.