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NCT Number: NCT06719414

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months

Secondary outcomes

  1. the specificity of models in prediction tumor response

    Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months

  2. the sensitivity of models in prediction tumor response

    Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months

  3. the positive predictive value of models in prediction tumor response

    Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months

  4. the negative predictive value of models in prediction tumor response

    Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months

  5. the accuracy of models in prediction tumor response

    Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months

  6. disease-free survival and overall survival

    Time frame: 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

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Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Collaborators

  • Xinyi People's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 5, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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