Using AI and MRI to predict treatment response in advanced rectal cancer
Predicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI
This study is testing if a new AI tool using MRI scans can help doctors predict how well treatment will work for people with advanced rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Guangzhou, Guangdong and 3 other locations) |
| Trial ID | NCT05523245 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a deep learning model that utilizes multi-parameter magnetic resonance imaging (MRI) to predict the effectiveness of neoadjuvant therapy in patients with locally advanced rectal cancer. By combining dynamic contrast-enhanced (DCE) imaging with conventional MRI, the study seeks to create a robust model for assessing treatment response and compare it with traditional MRI diagnostic methods. The ultimate goal is to accurately evaluate patients' complete response to treatment and enhance clinical decision-making.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with pathologically confirmed locally advanced rectal adenocarcinoma who have undergone preoperative neoadjuvant chemoradiotherapy.
Not a fit: Patients with poor MRI image quality, previous treatments for rectal cancer, or those with other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans for patients with locally advanced rectal cancer.
How similar studies have performed: Other studies utilizing AI and imaging techniques have shown promise in predicting treatment outcomes, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical suspicion or colonoscopic pathology of rectal cancer * Age over 18 years * Informed consent and signed informed consent form Exclusion Criteria: * Poor magnetic resonance image quality, such as severe artifacts * Previous treatment for rectal cancer * History or combination of other malignant tumours * Not Locally Advanced Rectal Cancer (LARC) * Not received neoadjuvant therapy or not completed neoadjuvant therapy * No surgery * Time interval between MRI and surgery was more than 2 weeks * Patients were lost to follow-up and voluntarily withdrew from the study due to adverse reactions or other reasons
Where this trial is running
Guangzhou, Guangdong and 3 other locations
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- The First Affiliated Hospital of Jinan University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Fifth Affiliated Hospital, Sun Yat-sen University — Zhuhai, Guangdong, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Xiaochun Meng
- Email: mengxch3@mail.sysu.edu.cn
- Phone: 13719166488
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.