RECRUITING

Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Diagnosis and Risk Assessment of Locally Advanced Rectal Cancer Using Co-registered Ultrasound and Photoacoustic Imaging

Quick Facts

Study Start:2023-05-01
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04339374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with any stage of rectal cancer undergoing surgical resection and the 3 surgeons and 1 radiologist as part of the reader team who diagnose the images obtained in these patients using the PAM/US probe.
  2. * Age \>18 years
  3. * Able to provide informed consent
  4. * In patients: Lesion located within 15cm of the anal verge
  1. * In patients: Inability to provide consent
  2. * In patients: Collection of intraoperative specimen for frozen section analysis will disqualify patients from participation

Contacts and Locations

Study Contact

William Chapman, Jr., M.D.
CONTACT
314-454-7177
chapmanjr@wustl.edu

Principal Investigator

William Chapman, Jr., M.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • William Chapman, Jr., M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Rectal cancer
  • Nonoperative management
  • Watch and wait
  • Complete clinical response

Additional Relevant MeSH Terms

  • Rectal Cancer
  • Colorectal Cancer