Application of Amide Proton Transfer-Weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer

NCT06719414 | Recruiting

• 1 other identifier: 2024ZSLYEC-552
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to learn about the amide proton transfer-weighted imaging for rectal cancer response assessment after neoadjuvant therapy. The main question it aims to answer is: • Does amide proton transfer-weighted imaging predict the cancer response before surgery? Participants will underwent amide proton transfer-weighted imaging as part of their regular MRI examination.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• the area under curve (AUC) of receiver operating characteristic (ROC) curves of models in prediction tumor response

  From date of baseline MRI to date of preoperative MRI，within 12 months

Secondary Outcomes (6)

• the specificity of models in prediction tumor response

  From date of baseline MRI to date of preoperative MRI，within 12 months

• the sensitivity of models in prediction tumor response

  From date of baseline MRI to date of preoperative MRI，within 12 months

• the positive predictive value of models in prediction tumor response

  From date of baseline MRI to date of preoperative MRI，within 12 months

• the negative predictive value of models in prediction tumor response

  From date of baseline MRI to date of preoperative MRI，within 12 months

• the accuracy of models in prediction tumor response

  From date of baseline MRI to date of preoperative MRI，within 12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer treated with neoadjuvant therapy

You may qualify if:

• Locally advanced rectal cancer(cT3-4, or cN+), resectable, histologically confirmed rectal adenocarcinoma
• Received neoadjuvant therapy before surgery
• Complete radical resection of rectal cancer and postoperative pathological examination
• Informed consent and signed the informed consent form

You may not qualify if:

• Poor image quality, such as severe artifacts
• Complicated with intestinal obstruction, intestinal perforation and other cases requiring surgical treatment
• The interval between preoperative MRI and surgery was more than 2 weeks
• Prior treatment for rectal cancer
• History of other malignant tumors
• Patients who cannot undergo MRI examination due to contraindications or relative contraindications
• Patients were lost to follow-up or voluntarily withdrew from the study due to adverse reactions or other reasons

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• Xinyi People's Hospital: collaborator

Study Sites (2)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Xinyi People's Hospital

Maoming, Guangdong, China

NOT YET RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Peiyi Xie

CONTACT

86+13724071514; xiepy6@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 5, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)