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

A Multi-center Study on Amide Proton Transfer-Weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06719414

Enrollment

320

Registered

2024-12-05

Start date

2024-10-22

Completion date

2028-12-01

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
disease-free survival and overall survival	From date of enrollement until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Countries

China

Contacts

CONTACTPeiyi Xie

xiepy6@mail.sysu.edu.cn86+13724071514

Outcome results