RadiotherapyNCT04700748
Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of Central Nervous System (CNS) Metastases
A study testing Brain metastases radiation in people with Radiotherapy and Brain Metastases, run by Lund University Hospital at 1 site in Sweden.
Trial summary
Stereotactic radiation therapy is an important and common method of treating brain metastases in patients with malignant disease. Today, however, there are no methods available to determine the metastasis' radiation sensitivity in advance and treatment responses can only be seen by changing of the size of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Brain Metastases, Sensitivity
- What is being tested?
- Brain metastases radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 28 Dec 2020to 26 May 2026
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients prescribed stereotactic radiation therapy to the brain, where MRI imaging is included in the treatment preparations.
- Cohesive remaining solid tumor component of ≥10mm.
- Age ≥18 years.
- World Health Organisation (WHO) performance status 0-1.
Who cannot join
- Inability to decide for oneself on participation in the study.
- Inability to understand the Swedish language.
- Metastases close to the base of the skull.
- Contraindications to conducting an MRI examination.
- Contraindications to obtaining contrast media during MRI examination.
- Expected survival less than 6 months.
- Previous radiation treatment to the same site in the brain, i.e. current treatment is a rope radiation.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of CNS Metastases
Stereotactic radiation therapy is an important and common method of treating brain metastases in patients with malignant disease. Today, however, there are no methods available to determine the metastasis' radiation sensitivity in advance and treatment responses can only be seen by changing of the size of the metastasis on conventional X-ray examinations, computed tomography (CT) and magnetic resonance imaging (MRI). Changes in the size of the metastases is something that is often seen weeks / months after treatment is completed. At Lund University Hospital, a new imaging technique, diffusional variance decomposition (DIVIDE), has now been developed. With this technique, the scatter in isotropic and anisotropic diffusion can be measured for each measuring point, which provides significantly more information about the properties of the tissue compared to current methods.
- Conditions
- Radiotherapy, Brain Metastases, Sensitivity, Radionecrosis
- Being tested
- Brain metastases radiation
- Keywords
- Diffusional variance decomposition, DIVIDE, Brain metastasis, Radiation treatment, Treatment response, Radionecrosis, Radiation damage, Radiation sensitivity, Magnetic resonance imaging
- Medical subject headings
- Brain Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain metastases radiationRadiation
Brain metastases radiation according to clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Diffusion-weighted MRI to predict treatment response in stereotactic radiotherapy of CNS metastases. | Other | Patients with brain metastases who will receive radiotherapy to the brain will undergo diffusion-weighted magnetic resonance imaging (MRI) at the same time as dose planning MRI is performed, after end of radiotherapy, and after 3 and 6 months after end of radiotherapy. Receives: Radiation: Brain metastases radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of radiation sensitivity to brain metastasis.
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Grade of radiation sensitivity to brain metastasis.
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after 3 months after end of treatment.
Grade of radiation sensitivity to brain metastasis.
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after 6 months after end of treatment.
Early changes in the tumor during and after completion of radiation therapy.
Evaluation done by MRI to see whether early changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Early changes in the tumor during and after completion of radiation therapy.
Evaluation done by MRI to see whether early changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after 3 months after end of treatment.
Early changes in the tumor during and after completion of radiation therapy.
Evaluation done by MRI to see whether early changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after 6 months after end of treatment.
Changes linked to treatment responses.
Evaluation done by MRI to see whether changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Changes linked to treatment responses.
Evaluation done by MRI to see whether changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after 3 months after end of treatment.
Changes linked to treatment responses.
Evaluation done by MRI to see whether changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after 6 months after end of treatment.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Evaluation done by MRI to see whether differentiation between radionecrosis and residual/recurrent tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Measured: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Evaluation done by MRI to see whether differentiation between radionecrosis and residual/recurrent tumor can be measured during radiotherapy after 3 months after end of treatment.
Measured: Is evaluated after 3 months after end of treatment.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Evaluation done by MRI to see whether differentiation between radionecrosis and residual/recurrent tumor can be measured during radiotherapy and after and 6 months after end of treatment.
Measured: Is evaluated after 6 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start28 Dec 2020
- Primary completion30 Apr 2024
- Study completion26 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700748
- Sponsor's protocol ID
- MR-SRS-001
- Status last verified
- Aug 2026
- First submitted
- 28 Dec 2020
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of CNS Metastases
- ClinicalTrials.gov ID
- NCT04700748
- Acronym / sponsor ID
- MR-SRS-001
- Conditions
- Radiotherapy, Brain Metastases, Sensitivity, Radionecrosis
- Keywords
- Diffusional variance decomposition, DIVIDE, Brain metastasis, Radiation treatment, Treatment response, Radionecrosis, Radiation damage, Radiation sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 8 Jan 2021 (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.
Stereotactic radiation therapy is an important and common method of treating brain metastases in patients with malignant disease. Today, however, there are no methods available to determine the metastasis' radiation sensitivity in advance and treatment responses can only be seen by changing of the size of the metastasis on conventional X-ray examinations, computed tomography (CT) and magnetic resonance imaging (MRI). Changes in the size of the metastases is something that is often seen weeks / months after treatment is completed. At Lund University Hospital, a new imaging technique, diffusional variance decomposition (DIVIDE), has now been developed. With this technique, the scatter in isotropic and anisotropic diffusion can be measured for each measuring point, which provides significantly more information about the properties of the tissue compared to current methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffusion-weighted MRI to predict treatment response in stereotactic radiotherapy of CNS metastases. | Other | Radiation: Brain metastases radiationPatients with brain metastases who will receive radiotherapy to the brain will undergo diffusion-weighted magnetic resonance imaging (MRI) at the same time as dose planning MRI is performed, after end of radiotherapy, and after 3 and 6 months after end of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients prescribed stereotactic radiation therapy to the brain, where MRI imaging is included in the treatment preparations.
- Cohesive remaining solid tumor component of ≥10mm.
- Age ≥18 years.
- World Health Organisation (WHO) performance status 0-1.
Key exclusion criteria (8 listed)
- Inability to decide for oneself on participation in the study.
- Inability to understand the Swedish language.
- Metastases close to the base of the skull.
- Contraindications to conducting an MRI examination.
- Contraindications to obtaining contrast media during MRI examination.
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 |
|---|---|---|
| Brain metastases radiationBrain metastases radiation according to clinical practice. | Radiation | Diffusion-weighted MRI to predict treatment response in stereotactic radiotherapy of CNS metastases. |
Primary outcome
Grade of radiation sensitivity to brain metastasis.
Time frame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Grade of radiation sensitivity to brain metastasis.
Time frame: Is evaluated after 3 months after end of treatment.
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Grade of radiation sensitivity to brain metastasis.
Time frame: Is evaluated after 6 months after end of treatment.
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Early changes in the tumor during and after completion of radiation therapy.
Time frame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Evaluation done by MRI to see whether early changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Early changes in the tumor during and after completion of radiation therapy.
Time frame: Is evaluated after 3 months after end of treatment.
Evaluation done by MRI to see whether early changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Early changes in the tumor during and after completion of radiation therapy.
Time frame: Is evaluated after 6 months after end of treatment.
Evaluation done by MRI to see whether early changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Changes linked to treatment responses.
Time frame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Evaluation done by MRI to see whether changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Changes linked to treatment responses.
Time frame: Is evaluated after 3 months after end of treatment.
Evaluation done by MRI to see whether changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Changes linked to treatment responses.
Time frame: Is evaluated after 6 months after end of treatment.
Evaluation done by MRI to see whether changes in the tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Time frame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Evaluation done by MRI to see whether differentiation between radionecrosis and residual/recurrent tumor can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Time frame: Is evaluated after 3 months after end of treatment.
Evaluation done by MRI to see whether differentiation between radionecrosis and residual/recurrent tumor can be measured during radiotherapy after 3 months after end of treatment.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Time frame: Is evaluated after 6 months after end of treatment.
Evaluation done by MRI to see whether differentiation between radionecrosis and residual/recurrent tumor can be measured during radiotherapy and after and 6 months after end of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain metastases radiation in people with Radiotherapy and Brain Metastases, run by Lund University Hospital at 1 site in Sweden.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 31 Aug 2026. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of radiation sensitivity to brain metastasis. (time frame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.). The study lists 12 primary outcomes in all. 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 31 Aug 2026.