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

NCT ID: NCT06719414

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-22

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinyi People's Hospital/Sixth Affiliated Hospital, Sun Yat-sen University Yuexi Hospital

UNKNOWN

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Peiyi Xie

associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Xinyi People's Hospital

Maoming, Guangdong, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Peiyi Xie

Role: CONTACT

Phone: 86+13724071514

Email: [email protected]

Facility Contacts

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Pieyi Xie

Role: primary

Xi Li

Role: primary

Other Identifiers

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2024ZSLYEC-552

Identifier Type: -

Identifier Source: org_study_id