Status:
UNKNOWN
Radiomics-based Artificial Intelligence System to Predict Neoadjuvant Treatment Response in Rectal Cancer
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborating Sponsors:
The Third Affiliated Hospital of Kunming Medical College.
Sir Run Run Shaw Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
In this study, investigators utilize a radiomics prediction model to predict the tumor response to neoadjuvant chemoradiotherapy (nCRT) before the nCRT is administered for patients with locally advanc...
Detailed Description
This is a multicenter, prospective, observational clinical study for validation of a radiomics-based artificial intelligence (AI) prediction model. Patients who have been pathologically diagnosed as r...
Eligibility Criteria
Inclusion
- pathologically diagnosed as rectal adenocarcinoma
- defined as clinical II-III staging (≥T3, and/or positive nodal status) without distant metastasis by enhanced Magnetic Resonance Imaging (MRI)
- intending to receive or undergoing neoadjuvant concurrent chemoradiotherapy (5-fluorouracil based chemotherapy, given orally or intravenously; Intensity-Modulated Radiotherapy or Volume-Modulated Radiotherapy delivered at 50 gray (Gy) in gross tumor volume (GTV) and 45 Gy in clinical target volume (CTV) by 25 fractions)
- intending to receive total mesorectum excision (TME) surgery after neoadjuvant therapy (not completed at the enrollment), and adjuvant chemotherapy
- MRI (high-solution T2-weighted imaging, contrast-enhanced T1-weighted imaging, and diffusion-weighted imaging are required) examination is completed before the neoadjuvant chemoradiotherapy
Exclusion
- with history of other cancer
- insufficient imaging quality of MRI to delineate tumor volume or obtain measurements (e.g., lack of sequence, motion artifacts)
- incomplete neoadjuvant chemoradiotherapy
- no surgery after neoadjuvant chemoradiotherapy resulting in lack of pathologic assessment of tumor response
- tumor recurrence or distant metastasis during neoadjuvant chemoradiotherapy
Key Trial Info
Start Date :
January 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04273477
Start Date
January 10 2020
End Date
December 1 2020
Last Update
February 18 2020
Active Locations (3)
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1
the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
2
The Third Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China, 650000
3
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310000