Brain MetastasesNCT06405256
Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases
An observational study of Brain Metastases, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- magnetic resonance imaging-guided adaptive radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2020to 18 Mar 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients from Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yuchao Ma, MD contact
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Science and Peking Union Medical College
Beijing
Nan Bi, MD, PhD, +861087788799, binan_email@163.com
About this study
Official title: 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)
Read the 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.
- Conditions
- Brain Metastases
- Being tested
- magnetic resonance imaging-guided adaptive radiotherapy
- Keywords
- Magnetic Resonance Imaging-guided Adaptive Radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging-guided adaptive radiotherapyRadiation
Stereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions)
| Study group | Role | What they receive |
|---|---|---|
| BM patients receiving MRIgART | For it's an observational study, all patients eligible will be divided into the group "BM patients receiving MRIgART" Receives: Radiation: magnetic resonance imaging-guided adaptive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
LCR will be calculated as the number of patients without intrathoracic tumor progression per RECIST Criteria.
Measured: 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)
Defined as the time from the date of radiation to the date of any documented death due to any cause.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: AEs and SAEs must be collected from the start of treatment to 28 days after discontinuation of radiation, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start3 Jan 2020
- Primary completion18 Mar 2025 (estimated)
- Study completion18 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nan Bi, MD, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405256
- Sponsor's protocol ID
- BMMRIgART
- Status last verified
- Mar 2024
- First submitted
- 4 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Displacement and Deformation Analysis of Adaptive Radiotherapy Based on MR-Linac for Large Brain Metastases
- ClinicalTrials.gov ID
- NCT06405256
- Acronym / sponsor ID
- BMMRIgART
- Conditions
- Brain Metastases
- Keywords
- Magnetic Resonance Imaging-guided Adaptive Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 18 Mar 2025 (estimated)
- Study completion
- 18 Mar 2025 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BM patients receiving MRIgART | – | Radiation: magnetic resonance imaging-guided adaptive radiotherapyFor it's an observational study, all patients eligible will be divided into the group "BM patients receiving MRIgART" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imaging-guided adaptive radiotherapyStereotactic Radiotherapy (with the prescribed dose of PTV 52-52.5 Gy, 13-15 fractions and Boost (if any) 60Gy, 15 fractions) | Radiation | BM patients receiving MRIgART |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
Related trials for Brain Metastases
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuchao Ma, MD contact
Nan Bi, MD principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Bi, MD (8601087788799, binan_email@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.