Post-Neoadjuvant Treatment MRI Based AI System to Predict pCR for Rectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 322
Summary
- Conditions
- Rectal Cancer
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This is a multicenter, prospective, observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with locally advanced rectal cancer (LARC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data. Patients who have been...
This is a multicenter, prospective, observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with locally advanced rectal cancer (LARC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data. Patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical II-III stage will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University, Sir Run Run Shaw Hospital and the Third Affiliated Hospital of Kunming Medical College. All participants should follow a standard treatment protocol, including neoadjuvant treatment, total mesorectum excision (TME) surgery. Patients with LARC who received neoadjuvant treatment will be enrolled and their post-neoadjuvant treatment MRI images will be used to predict their pathologic response (pCR vs. non-pCR). The artificial intelligence prediction system and the expert radiologist will define the pathologic response as pCR or non-pCR, respectively. The pathologist will provide the final pathology report of TME surgery specimen (pCR or non-pCR) as a standard. The predictive efficacy of these two back-to-back approaches generated will be compared in this multicenter, prospective clinical study.
Tracking Information
- NCT #
- NCT04278274
- Collaborators
- Sir Run Run Shaw Hospital
- The Third Affiliated Hospital of Kunming Medical College.
- Investigators
- Study Chair: Xiangbo Wan, MD, PhD Sixth Affiliated Hospital, Sun Yat-sen University Principal Investigator: Weidong Han, MD, PhD Sir Run Run Shaw Hospital Principal Investigator: Zhenhui Li, MD The Third Affiliated Hospital of Kunming Medical College.