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

NCT06742021 | Recruiting

• 1 other identifier: KYLX2024-272
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor treatment response evaluation

  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

Study Arms (1)

Application Value of MRI Imaging in Treatment Decision-Making for Lung Cancer

EXPERIMENTAL

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

Interventions

Application Value of MRI Imaging in Treatment Decision-Making for Lung Cancer DIAGNOSTIC_TEST

Chest MRI scans outside of the standard treatment protocol

Application Value of MRI Imaging in Treatment Decision-Making for Lung Cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lianhua Ye

  Ethics Committee of Yunnan Provincial Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

zhihui shi

CONTACT

15087838660; 3332105746@qq.com

Zhenhui Li

CONTACT

13698736132; lizhenhui@kmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

CN (1)