Clinical trial · Interventional
Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
Diagnosis and Risk Assessment of Locally Advanced Rectal Cancer Using Co-registered Ultrasound and Photoacoustic Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endorectal photoacoustic imaging probe | Device | — | UNRESOLVED |
| Photoacoustic imaging, photoacoustic microscopy | Device | — | UNRESOLVED |
| Reader Performance | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- In vivo imaging
- description
- * 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. 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 may then be imaged ex vivo as deemed necessary. * For this portion of the study, enrollment will be limited to a total of 86 participants
- interventionNames
- Device: Photoacoustic imaging, photoacoustic microscopy
- Device: Endorectal photoacoustic imaging probe
- type
- EXPERIMENTAL
- label
- Reader Team
- description
- 3 surgeons and 1 radiologist will be initially trained to grade lesions using the PAM/US image from the first set of 30 patients (Group 1). They will then use the PAM/US data to grade lesions obtained from the second set of 56 patients after initial training (Group 2).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLeng 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. PMID 33754826