Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases

May 4, 2024 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Displacement and Deformation Analysis of Adaptive Radiotherapy Based on MR-Linac for Large Brain Metastases

This study is an ambispective cohort study to evaluate the displacement and deformation of large brain metastases (BM) treated with magnetic resonance imaging-guided adaptive radiotherapy (MRIgART)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients had a pathologically confirmed malignant cancer and were diagnosed with brain metastases (BM) by enhanced magnetic resonance imaging (MRI) with BM volume of 2cm and above. All patients received Unity MR-linac adaptive radiotherapy. Gross tumor volume (GTV) and organs at risk (OARs) were re-delineated for every image set and analyzed for displacement and deformation.

Study Type

Observational

Enrollment (Estimated)

20

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
      • Beijing, China
        • Recruiting
        • Chinese Academy of Medical Science and Peking Union Medical College
        • Contact:

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients from Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Description

Inclusion Criteria:

  1. Age ≥ 18 years; KPS score ≥ 60.
  2. pathologically confirmed lung cancer.
  3. diagnosed with brain metastases by enhanced MRI.
  4. BM volume ≥ 2cm.
  5. Anticipated time to survival>3 months.
  6. Treated with Unity MR-linac.
  7. Good compliance; Able to stay still in supine position for 45 minutes and above.

Exclusion Criteria:

  1. Fail to complete radiotherapy as planned; Anticipated time to survival less than 3 months.
  2. Suffer from severe back pain in supine position, unable to receive Unity MR-linac.
  3. Suffer from severe claustrophobia.
  4. Incomplete pre-Unity image data.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BM patients receiving MRIgART
For it's an observational study, all patients eligible will be divided into the group "BM patients receiving MRIgART"
Radiation: magnetic resonance imaging-guided adaptive radiotherapy
Stereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-cranial progression-free survival (IPFS)
Time Frame: From the date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first, assessed up to 12 months.
Defined as the time from date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first.
From the date of radiation until the date of first documented intracalcarine recurrence or progression, or date of death from any cause, whichever came first, assessed up to 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control rate (LCR)
Time Frame: Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.
LCR will be calculated as the number of patients without intrathoracic tumor progression per RECIST Criteria.
Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.
Overall survival (OS)
Time Frame: From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months.
Defined as the time from the date of radiation to the date of any documented death due to any cause.
From the date of radiation until the date of any documented death due to any cause,, assessed up to 12 months.
Objective Response Rate (ORR)
Time Frame: Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.

The objective response rate (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria.

Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.
Disease control rate (DCR)
Time Frame: Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.

DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria.

Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.
Tumor assessment using RECIST will be performed at baseline then every 3 months from first treatment until objective progression or death from any cause, assessed up to 12 months.
Adverse Event
Time Frame: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.
The incidence of adverse events (AEs) and serious adverse events (SAEs) is evaluated by EORTC/RTOG Radiation Grading System Criteria and CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.
AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.

Collaborators and Investigators

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

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Nan Bi, MD, Chinese Academy of Medical Sciences and Peking Union Medical College

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)

January 3, 2020

Primary Completion (Estimated)

March 18, 2025

Study Completion (Estimated)

March 18, 2025

Study Registration Dates

First Submitted

May 4, 2024

First Submitted That Met QC Criteria

May 4, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMMRIgART

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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