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NCT04339374Recruiting

Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer

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

Source: ClinicalTrials.gov · Last updated 12 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
30 Mar 2020
Start date
1 May 2023
Primary completion date
31 Dec 2028
Lead sponsor
Washington University School of Medicine
NCT number
NCT04339374

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 1 May 2023 to the primary completion date, 31 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Colorectal surgeons or radiologists who treat or interpret imaging regularly for patients with rectal cancer.

Other

  • Inability to provide consent
  • Collection of intraoperative specimen for frozen section analysis will disqualify patients from participation
    • Eligibility Criteria Readers:

Who the study is looking for

  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.