Ultrasound and Photoacoustic Imaging of Colon and Rectal Tumor Tissue

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04339374
• Other study ID #: 201707066
• Status: Recruiting
• Start date: July 19, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: William Chapman, Jr., M.D.
• Phone: 314-454-7177
• Email: chapmanjr[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Performance characteristics of the novel endorectal ultrasound probe as measured by number of adverse events		Approximately 60 minutes
Secondary	Performance characteristics of the novel endorectal ultrasound probe as measured by evidence of tissue damage from the imaging laser		Approximately 60 minutes
Secondary	Performance characteristics of the novel endorectal ultrasound probe as measured by time required to complete study		Approximately 60 minutes
Secondary	Performance characteristics of the novel endorectal ultrasound probe as measured by variability in image production		Approximately 60 minutes

External Links

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