Application of Amide Proton Transfer-Weighted Imaging in... | NCT06719414

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

NCT06719414

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Status

Recruiting

Last Update Posted

Jan 27, 2026Actual

Enrollment

320Estimated

Phase

Not provided

Conditions

Rectal Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2024Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Nov 27, 2024

First Submission Date that Met QC Criteria

Dec 3, 2024

First Posted Date

Dec 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2026

Last Update Posted Date

Jan 27, 2026Actual

Name	Class
Xinyi People's Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with locally advanced rectal cancer treated with neoadjuvant therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peiyi Xie	Contact	86+13724071514		xiepy6@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sixth Affiliated Hospital, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510655	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided