New imaging technique for diagnosing rectal cancer
Diagnosis and Risk Assessment of Locally Advanced Rectal Cancer Using Co-registered Ultrasound and Photoacoustic Imaging
This study is testing a new imaging tool to see if it can help doctors better identify rectal cancer patients who no longer need surgery after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT04339374 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a novel endorectal photoacoustic ultrasound imaging device designed to assess rectal tumor response in patients with rectal cancer. By combining this imaging technique with deep-learning algorithms, the study seeks to improve the accuracy of identifying patients who have achieved a complete clinical response to preoperative treatment. The goal is to reduce unnecessary surgeries while maintaining high sensitivity for detecting residual cancer. Approximately 86 patients who have completed neoadjuvant therapy will be recruited to validate the effectiveness of this imaging tool.
Who should consider this trial
Good fit: Ideal candidates include patients with any stage of rectal cancer who have completed neoadjuvant therapy and are considering surgical resection or nonoperative management.
Not a fit: Patients who are unable to provide informed consent or require intraoperative specimen analysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the number of unnecessary surgeries for rectal cancer patients while ensuring accurate identification of those needing surgical intervention.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Patients: * Patients with any stage of rectal cancer undergoing surgical resection. * Age \>18 years * Able to provide informed consent Additional Inclusion Criterion for in vivo imaging (patients): * Lesion located within 15cm of the anal verge Exclusion Criteria Patients: * Inability to provide consent * Collection of intraoperative specimen for frozen section analysis will disqualify patients from participation Eligibility Criteria Readers: * Colorectal surgeons or radiologists who treat or interpret imaging regularly for patients with rectal cancer.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: William Chapman, Jr., M.D. — Washington University School of Medicine
- Study coordinator: William Chapman, Jr., M.D.
- Email: chapmanjr@wustl.edu
- Phone: 314-454-7177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.