Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics

Locally Advanced Rectal Cancer Clinical Trial

Official title:

Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238885
• Other study ID #: RCpCR-MR-Radiomics
• Status: Completed
• Start date: March 1, 2013
• Est. completion date: January 21, 2019

Study information

• Verified date: January 2019
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.

Description:

We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: January 21, 2019
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pathologically proved rectal cancer

• locally advanced rectal cancer (=T3 or N+)

• a distance less than 12cm between the lower edge of tumor and the anal margin

• no evidence of distant metastases

• no prior anti-cancer therapy before treatment

• scheduled to receive preoperative CRT

Exclusion Criteria:

• history or concurrent of other malignancy

• incomplete preoperative CRT

• failed to receive surgery or unavailable pCR assessment

• poor quality of MR images for measurement

• patient quit

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Diagnostic Test:
• pelvic MR examination
All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sun Ying-Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response(pCR)	Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.	within one week after surgery