Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
Recruiting · NCT05316103 · Interventional (participants receive a specific treatment) · Lead sponsor: Nanfang Hospital, Southern Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Probe-based confocal laser endomicroscopy targeted optical biopsy
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age from over 18 to under 80 years
- American Society of Anesthesiology(ASA) score class I,II,or III
- Locally advanced rectal cancer
- Patient has completed standard neoadjuvant therapy
- Expected surgical resection
- Written informed consent
Exclusion criteria
- Pregnant or lactating women
- Acute renal insufficiency or stage II to IV chronic renal insufficiency
- Patients with allergic constitution
Where it is running
1 location listed.
- Nanfang Hospital, Southern Medical University - Guangzhou, Guangdong, China