RecruitingNot ApplicableNCT04339374

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

Sponsor

Washington University School of Medicine

Enrollment

90 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Rectal Cancer

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a new imaging technology — combining standard ultrasound with a technique called photoacoustic imaging (which uses light and sound waves) — to improve how doctors can tell apart different types and stages of rectal cancer before and during surgery. Better imaging could help surgeons make more precise treatment decisions. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with rectal cancer at any stage and are scheduled for surgical removal - Your tumor is within 15 cm of the anus (for the in-body scanning part of the study) - You are able to provide informed consent - You are a colorectal surgeon or radiologist who regularly treats or reads imaging for rectal cancer patients (for the reader study component) **You may NOT be eligible if...** - You are unable to consent to the study - Frozen section analysis (a specific intraoperative test) of your specimen is being collected at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhotoacoustic imaging, photoacoustic microscopy

-Emerging technique in which a short-pulsed laser beam penetrates diffusely into a tissue sample, causing the release of acoustic waves due to a transient temperature rise -The transient acoustic waves, or photoacoustic waves, are then measured around the sample by US transducers -The resolution of the devices can be altered by changing the wavelengths of laser light and spectrum analysis of the receiver. In this manner, human colorectal pathology will be examined under multiple types of photoacoustic ranges (broadly termed photoacoustic microscopy and photoacoustic imaging). The study has two phases. In the second phase, the investigators will provide assessments of treated rectum based on clinical information and photoacoustic information after initial training.

DEVICEEndorectal photoacoustic imaging probe

-An endorectal imaging device using coregistered photoacoustic and ultrasound imaging has been constructed. This probe is used to perform in vivo imaging among patients with rectal pathology intraoperatively.

OTHERReader Performance

After initial training using Group 1 data, readers will classify lesions as non-clinical complete responders (non-cCR) or clinical complete responders (cCR) based on standard-of-care (SOC) information. Following PAM/US imaging, readers will reassess lesion status using PAM/US data. PAM/US model outputs will be generated for each patient and compared with reader assessments. For patients undergoing surgery, tumor regression scores from surgical specimens will be compared with reader assessments and model outputs. For patients under nonoperative surveillance, clinical response at 2-year follow-up will be compared with model outputs. The study will evaluate whether PAM/US assistance improves residual tumor detection in Group 2 patients. As the model is under development, it will be iteratively retrained and tested as new data become available.