Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer

Conditions

• Colorectal Cancer
• Rectal Cancer

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 1, 2023

Status verified

Feb 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

90 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Other: In vivo imaging
  * Patients with distal rectal lesions (benign or malignant tumors within 15cm of the anal verge) will be enrolled for the in vivo imaging portion of the study * Participation will include an intraoperative, in vivo evaluation of the tumor with a novel endorectal photoacoustic ultrasound probe. Following the induction of anesthesia, patients will undergo a 20-minute endorectal imaging evaluation performed by their colorectal surgeon. After imaging, the patient will then undergo standard-of-care surgical resection of the rectum. The resection specimen may then be imaged ex vivo as deemed necessary. * For this portion of the study, enrollment will be limited to a total of 86 participants
• Experimental: Reader Team
  3 surgeons and 1 radiologist will be initially trained to grade lesions using the PAM/US image from the first set of 30 patients (Group 1). They will then use the PAM/US data to grade lesions obtained from the second set of 56 patients after initial training (Group 2).

Primary Outcome Measure

Number of patients that readers are able to diagnose with rectal cancer [ Time Frame: Approximately 15 minutes ]

Central Contacts

• William Chapman, Jr., M.D.
  314-454-7177
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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