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NCT04339374 · ClinicalTrials.gov registry record · NA

Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer

A NA study of Colorectal Cancer and Rectal Cancer, sponsored by Washington University School of Medicine.

Recruiting
Registry status
NA
Development phase
90
Enrollment target
1
Study location

NCT04339374: Recruiting NA study of Colorectal Cancer and Rectal Cancer, sponsored by Washington University School of Medicine.

NCT04339374 is a NA study of Colorectal Cancer and Rectal Cancer that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 90 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04339374, a NA study of Colorectal Cancer and Rectal Cancer, is actively recruiting participants, sponsored by Washington University School of Medicine.

RECRUITING
Registry status
NA
Development phase
90 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Interventions

  • DEVICE Photoacoustic imaging, photoacoustic microscopy
  • DEVICE Endorectal photoacoustic imaging probe
  • OTHER Reader Performance

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2023-05-01
Est. Completion 2028-12-31
Phase NA

What NCT04339374 shows while recruiting

NCT04339374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (94% lower).

The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Photoacoustic imaging, photoacoustic microscopy is the first listed.

NCT04339374 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT04339374 about?

NCT04339374 is a clinical study titled "Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer". 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 preop...

What is the current status of trial NCT04339374?

This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2023-05-01. Estimated completion is 2028-12-31.

What conditions does trial NCT04339374 study?

This clinical trial studies the following conditions: Colorectal Cancer, Rectal Cancer.

What interventions are being tested in trial NCT04339374?

The interventions under investigation include: Photoacoustic imaging, photoacoustic microscopy (DEVICE), Endorectal photoacoustic imaging probe (DEVICE), Reader Performance (OTHER).

Who is sponsoring clinical trial NCT04339374?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04339374 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04339374's enrollment target sits among peer trials

90 225th of 381 higher than 156 of 381 other Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04339374, the US trial registry maintained by the National Library of Medicine. NCT04339374 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.