Application of DCE-MRI Based on 4D FreeBreathing in Predicting the Efficacy of Immune and Targeted Therapy in Lung Cancer

December 15, 2024 updated by: Yunnan Cancer Hospital
This study aims to address the challenge of predicting the efficacy of targeted and immunotherapy in lung cancer patients. By utilizing two DCE-MRI images-one before treatment and one after one treatment cycle-along with the patients' clinical and pathological information, we aim to achieve accurate prediction of the therapeutic efficacy of targeted and immunotherapy in lung cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
          • Guojun Zhang
          • Phone Number: r 0871-68173640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Tumor size greater than 2 cm
  2. Age between 18 and 75 years

Exclusion Criteria:

  1. Presence of MRI contraindications (e.g., metal implants, pacemaker implantation, etc.)
  2. Allergy to gadolinium contrast agents
  3. Lesions difficult to delineate on images due to conditions such as atelectasis or diffuse lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Application Value of MRI Imaging in Treatment Decision-Making for Lung Cancer
A Philips 3.0T MRI scanner was used, with a dStream Torso 32-channel coil. DCE-MRI was performed using a free-breathing sequence with a flow velocity of 3.0 m/s. The image quality assessment in this study was performed by two radiologists (one with 3 years of diagnostic experience and the other with 15 years of diagnostic experience), including both subjective and objective evaluations. Then, dynamic information from the 4D FreeBreathing DCE-MRI images taken before treatment and one week after immunotherapy/targeted therapy, along with routine clinical and pathological data, were used to construct predictive models for the efficacy of immunotherapy and targeted therapy. Finally, the MRI model was compared with the CT model, and the performance of both models was evaluated.
Diagnostic test: Application Value of MRI Imaging in Treatment Decision-Making for Lung Cancer
Chest MRI scans outside of the standard treatment protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor treatment response evaluation
Time Frame: within one week before treatment and two weeks after treatment completion
This study aims to evaluate tumor treatment response using the RECIST V1.1 criteria, based on CT images taken within one week before treatment and two weeks after treatment completion.
within one week before treatment and two weeks after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunnan Cancer Hospital

Investigators

  • Study Director: Lianhua Ye, Ethics Committee of Yunnan Provincial Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 15, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLX2024-272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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