Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
NCT05316103 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2023-05-12
Summary
Currently, low concordance (36%) is found between clinical complete response and pathologic complete response in patients with rectal cancer after neoadjuvant chemoradiotherapy. Probe-based confocal laser endoscopy (pCLE) provides a promising targeted optical biopsy to evaluate the response to neoadjuvant chemoradiotherapy. The aim of this study is to investigate whether pCLE-targeted optical biopsy can improve the accuracy of preoperative endoscopic biopsy for local rectal scars in rectal cancer patients after neoadjuvant chemoradiotherapy.
Conditions
Interventions
- DEVICE
-
Probe-based confocal laser endomicroscopy targeted optical biopsy
After intravenous injection of fluorescein sodium, pCLE-based targeted optical biopsy will be performed.
Sponsors & Collaborators
-
Nanfang Hospital, Southern Medical University
lead OTHER
Principal Investigators
-
Jun Yan, M.D., Ph.D. · Nanfang Hospital, Southern Medical University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-04
- Primary Completion
- 2026-11-01
- Completion
- 2026-11-01
Countries
- China
Study Locations
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