Targeted optical biopsy for rectal cancer scars after treatment
Use of Probe-based Confocal Laser Endomicroscopy to Perform Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
NA · Nanfang Hospital, Southern Medical University · NCT05316103
This study is testing a new way to take more accurate biopsies from rectal cancer patients after treatment to see if it helps doctors better understand how well the treatment worked.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05316103 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of probe-based confocal laser endoscopy (pCLE) to improve the accuracy of preoperative endoscopic biopsies in rectal cancer patients who have undergone neoadjuvant chemoradiotherapy. Patients with locally advanced rectal cancer will receive both traditional endoscopic biopsies and pCLE-targeted optical biopsies to evaluate local rectal scars. The goal is to enhance the concordance between clinical and pathologic complete responses, which currently stands at only 36%. By utilizing real-time histological examination, this approach aims to provide more reliable assessments of treatment response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with locally advanced rectal cancer who have completed standard neoadjuvant therapy.
Not a fit: Patients who are pregnant, have severe renal insufficiency, or have allergic constitutions may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could lead to more accurate evaluations of treatment response in rectal cancer patients, potentially improving patient management and outcomes.
How similar studies have performed: While the use of pCLE is a novel approach, similar studies in other cancer types have shown promising results in improving diagnostic accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age from over 18 to under 80 years 2. American Society of Anesthesiology(ASA) score class I,II,or III 3. Locally advanced rectal cancer 4. Patient has completed standard neoadjuvant therapy 5. Expected surgical resection 6. Written informed consent Exclusion Criteria: 1. Pregnant or lactating women 2. Acute renal insufficiency or stage II to IV chronic renal insufficiency 3. Patients with allergic constitution
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Principal investigator: Jun Yan, M.D., Ph.D. — Nanfang Hospital, Southern Medical University
- Study coordinator: Jun Yan, M.D., Ph.D.
- Email: yanjunfudan@163.com
- Phone: 086-13825066546
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.
Conditions: Rectal Cancer, rectal cancer, confocal laser endomicroscopy, optical biopsy