Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
Recruiting · NCT04339374 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States