Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-10

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics

NCT03238885

Locally Advanced Rectal Cancer

COMPLETED

MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer

NCT05609149

Rectal Cancer

COMPLETED

Predicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI

NCT05523245

Rectal Cancer

RECRUITING

Application of Multimodal MRI in Histological Grading and Prognostic Assessment of Rectal Cancer

NCT07269912

Rectal Neoplasms Prognosis

NOT_YET_RECRUITING

Application of PET/MRI in the Evaluation of the Efficacy of Neoadjuvant Therapy for Locally Advanced Rectal Cancer

NCT06653452

Locally Advanced Rectal Cancer (LARC)

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We proposed to constructed multi-parameter predictive model for predicting therapeutic response and pathological complete response(pCR) of patients with rectal cancer who received neoadjuvant chemoradiation. MR radiomics,convolutional neural networks, morphological parameters and quantitative functional parameters derived from diffusion-weighted MR images will be integrated for model construction.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Assessing response with MRI

Preoperative chemo-radiotherapy as standard treatment. Neoadjuvant therapy (long course intensity modulated radio-chemotherapy, GTV 50.6Gy, totally 22 fractions; Capecitabine 825mg/m2 /bid by oral administration).

Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.

All patients are scheduled to receive total mesorectal excision surgery 12-14 weeks after the completion of preoperative chemo-radiotherapy.

Group Type EXPERIMENTAL

three MR examination

Intervention Type DEVICE

Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

three MR examination

Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

imaging

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \> 18 years
* T3/4 or node positive biopsy-proved primary rectal cancer
* Suitable for pre-operative chemoradiotherapy and surgical resection
* No contraindication to MRI
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

* History or concurrent of other cancer
* Previous therapy to pelvis
* Unable/unwilling to have MRI
* Pacemaker or implanted defibrillator
* Pregnancy, lactation or inadequate contraception
* Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study
* Unwilling or unable to give informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No