Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases

NCT06405256 | Recruiting

• 1 other identifier: BMMRIgART
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Brain Metastases

Keywords

Magnetic Resonance Imaging-guided Adaptive Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Intra-cranial progression-free survival (IPFS)

  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 Outcomes (5)

• Local control rate (LCR)

  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)

  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)

  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)

  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

  AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.

Study Arms (1)

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

Interventions

magnetic resonance imaging-guided adaptive radiotherapy RADIATION

Stereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions)

BM patients receiving MRIgART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Science and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nan Bi, MD

  Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Bi, MD

CONTACT

8601087788799; binan_email@163.com

Yuchao Ma, MD

CONTACT

mycbyts@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 8, 2024
• Study Start: January 3, 2020
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-03

Locations

CN (1)