Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06405256
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nan Bi, MD
Principal Investigator Affiliation Chinese Academy of Medical Sciences and Peking Union Medical College
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Metastases
Additional Details

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.

Arms & Interventions

Arms

: BM patients receiving MRIgART

For it's an observational study, all patients eligible will be divided into the group "BM patients receiving MRIgART"

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, China

Status

Recruiting

Address

Chinese Academy of Medical Science and Peking Union Medical College

Beijing, ,

Site Contact

Nan Bi, MD, PhD

[email protected]

+861087788799

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