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RecruitingNCT06719414Updated Jan 27, 2026

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

An observational study in Rectal Cancer, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
320
Sex
All
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Study 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.
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Conditions studied

  • Rectal Cancer

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 320 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 211 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with locally advanced rectal cancer treated with neoadjuvant therapy

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
320 participants (estimated)
Patient registry
No
06

What researchers measure

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

07

Study locations

1 of 2 sites recruiting
  • Sixth Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510655, China
    Recruiting
  • Xinyi People's Hospital
    Maoming, Guangdong, China
    • Xi Li · Contact · 86+18938380811
    Not yet recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06719414
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators
Xinyi People's Hospital
Responsible party
Peiyi Xie (associate chief physician, Sixth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Dec 5, 2024
Start date
Oct 22, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jan 27, 2026

Study contacts

Peiyi Xie
Contact
xiepy6@mail.sysu.edu.cn
86+13724071514

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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