Ultrasound and Photoacoustic Imaging of Colon and Rectal Tumor Tissue

Pilot Study of Ultrasound and Photoacoustic Imaging of Colon and Rectal Tumor Tissue

The purpose of this pilot study is to a) explore the photoacoustic properties of normal, polypoid, and malignant colorectal tissue and b) demonstrate the functionality of a novel endorectal photoacoustic ultrasound probe in humans with rectal cancer. The study includes two parts. The initial exploratory portion will be conducted ex vivo with resected colon and rectal specimens immediately following surgical excision. Based on those findings, an endorectal probe will then be constructed to examine in vivo tumors. The investigators hypothesize that in vivo photoacoustic imaging will be capable of differentiating normal from malignant tissue.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Device: Photoacoustic imaging, photoacoustic microscopy; Device: Endorectal photoacoustic imaging probe

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: William Chapman, Jr., M.D.; Phone Number: 314-454-7177; Email: chapmanjr@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Matthew Mutch, M.D.
      • Sub-Investigator: Paul Wise, M.D.
      • Sub-Investigator: Quing Zhu, Ph.D.
      • Contact: William Chapman, Jr., M.D.; Phone Number: 314-454-7177; Email: chapmanjr@wustl.edu
      • Principal Investigator: William Chapman, Jr., M.D.
      • Sub-Investigator: Deyali Chatterjee, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

-Patients seen at Washington University School of Medicine

Description

Inclusion Criteria:

• Patients with adenomatous polyps or any stage colorectal cancer undergoing surgical resection without intraoperative frozen section analysis
• Age >18 years
• Able to provide informed consent

Additional Inclusion Criterion for in vivo imaging

-Lesion located within 15cm of the anal verge

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ex vivo imaging; Patients with known adenomatous polyps or malignancies in the colon or rectum undergoing resection will be considered for enrollment; Participation will include imaging of both normal and known pathologic portions of the specimen ex vivo immediately following resection. The specimen will then undergo fixation and standard pathologic evaluation, with subsequent correlation between imaging and pathologic findings.; This data will also be used to develop a convolutional neural network (CNN) to assist in interpreting photoacoustic imaging data.	Device: Photoacoustic 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 is strictly observational as specimen imaging will have no impact on the clinical decision-making for the participants; Other Names: PAM; PAI; Device: Endorectal photoacoustic imaging probe; Based on data gathered in the ex vivo cohort of patients, an endorectal imaging device using coregistered photoacoustic and ultrasound imaging will be constructed. This probe will then be used to perform in vivo imaging among patients with rectal pathology intraoperatively.; The study is strictly observational as specimen imaging will have no impact on the clinical decision-making for the participants; Other Names: PAM; PAI; Coregistered photoacoustic ultrasound imaging
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 as well as ex vivo imaging post-resection as described above. 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 will then be imaged ex vivo as performed in the "ex vivo cohort" of this study.; For this portion of the pilot, enrollment will be limited to 40 participants	Device: Photoacoustic 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 is strictly observational as specimen imaging will have no impact on the clinical decision-making for the participants; Other Names: PAM; PAI; Device: Endorectal photoacoustic imaging probe; Based on data gathered in the ex vivo cohort of patients, an endorectal imaging device using coregistered photoacoustic and ultrasound imaging will be constructed. This probe will then be used to perform in vivo imaging among patients with rectal pathology intraoperatively.; The study is strictly observational as specimen imaging will have no impact on the clinical decision-making for the participants; Other Names: PAM; PAI; Coregistered photoacoustic ultrasound imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the receiver operating curve (ROC)	-The purpose of this study is to develop and pilot imaging technology that will aid in the differentiation of malignant from normal colorectal tissue. As such, the primary endpoint is the differentiating capability of the endorectal coregistered probe, to be measured as the AUC or area under the receiver operating curve. This primary endpoint to be measured in both the ex vivo and in vivo portions of this study. This will also be used to compare performance of the classification neural network with ultrasound alone compared to ultrasound coupled with photoacoustic techniques.	Approximately 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize both in and ex vivo tissue samples with photoacoustic imaging	This outcome will be measured qualitatively by comparing histologic findings to the experimental imaging. The critical features to be analyzed in each image are the cross-sectional structure of normal colorectal tissues in comparison to the loss of a layered structure and its corresponding evenly distributed vascular pattern in the setting of neoplasia.	Approximately 60 minutes
Performance characteristics of the novel endorectal ultrasound probe as measured by number of adverse events		Approximately 60 minutes
Performance characteristics of the novel endorectal ultrasound probe as measured by evidence of tissue damage from the imaging laser		Approximately 60 minutes
Performance characteristics of the novel endorectal ultrasound probe as measured by time required to complete study		Approximately 60 minutes
Performance characteristics of the novel endorectal ultrasound probe as measured by variability in image production		Approximately 60 minutes

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: William Chapman, Jr., M.D., Washington University School of Medicine

Publications and helpful links

General Publications

• Leng X, Uddin KMS, Chapman W Jr, Luo H, Kou S, Amidi E, Yang G, Chatterjee D, Shetty A, Hunt S, Mutch M, Zhu Q. Assessing Rectal Cancer Treatment Response Using Coregistered Endorectal Photoacoustic and US Imaging Paired with Deep Learning. Radiology. 2021 May;299(2):349-358. doi: 10.1148/radiol.2021202208. Epub 2021 Mar 23.

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 201707066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data available for sharing - Code and de-identified patient data related to this project will be made available upon request to other academic entities following the publication of project-related results.; Data to be shared - Individual participant data, along with code related to the novel neural network developed, that underlie the results reported herein. Data will not be shared until deidentified.; With whom will data be shared - academic entities approved by the primary research team
• IPD Sharing Time Frame: Data will be made available to approved persons between 12 and 36 months after publication of these results
• IPD Sharing Access Criteria: Purpose of accessing data - any purpose allowed.; Mechanism for sharing data - data to be shared via institutional file sharing service once appropriate parties have been approved by the research team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No