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Ultrasound and Photoacoustic Imaging for Rectal Cancer Diagnosis

This study is testing a new device that combines photoacoustic imaging (using light to create sound waves) and ultrasound imaging to better diagnose rectal cancer. Researchers want to see if this new endorectal (inside the rectum) imaging probe can accurately tell if rectal tumors have responded well to pre-surgery treatment. The goal is to reduce unnecessary surgeries for patients whose cancer has completely responded to treatment, while still catching any remaining cancer. You might be able to join if you are an adult (19 or older) with any stage of rectal cancer undergoing surgery, and your lesion is within 15cm of the anal opening. The study aims to enroll 90 participants. The study's status is currently unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 90 participants.
What's involved
You would undergo imaging with the endorectal photoacoustic imaging probe during surgery. Your lesion status would be reassessed using this new imaging data.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure the number of patients without surgery who cleared as clinical complete responders (cCR) after 2 years of follow-up.

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NCT04339374

Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer

Recruiting
NAAges 19+Interventional
Washington University School of Medicine
~90 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:Photoacoustic imaging, photoacoustic microscopyEndorectal photoacoustic imaging probeReader Performance

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients that readers are able to diagnose with rectal cancer
Measured over Approximately 15 minutes
+1 more outcome measured

Conditions

Rectal Cancer
Colorectal Cancer

Explore related trials

Rectal Carcinoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • William Chapman, Jr., M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

William Chapman, Jr., M.D.
[email protected]
314-454-7177
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with any stage of rectal cancer undergoing surgical resection.
Age \>18 years
Able to provide informed consent
Lesion located within 15cm of the anal verge

Exclusion

Inability to provide consent
Collection of intraoperative specimen for frozen section analysis will disqualify patients from participation
Colorectal surgeons or radiologists who treat or interpret imaging regularly for patients with rectal cancer.

What this trial measures

  • Number of patients that readers are able to diagnose with rectal cancerApproximately 15 minutes

    The primary endpoint is to see if the readers trained to use the co-registered PAM/US data are able to diagnose rectal cancers with better sensitivity \& specificity using surgery pathology results as the ground truth. SOC sensitivity and specificity will be computed based on readers' cCR vs. non-cCR. The sensitivity and specificity with additional PAM/US data will be computed based on readers' revised cCR vs. non-cCR. PAM/US model sensitivity and specificity will also be computed using surgery pathology results.

  • Number of patients without surgery who cleared as cCR after 2-years of follow-up2-years of follow-up

    The secondary primary endpoint is the sensitivity and specificity of readers' cCR vs. non-cCR assessments using SOC and sensitivity and specificity of PAM/US models cCR vs. non-cCR reassessments PAM/US data. The "ground truth " of this cohort will be no cancer recurrence based on clinical data.