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Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of Central Nervous System (CNS) Metastases

Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of CNS Metastases

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04700748
Enrollment
150
Registered
2021-01-08
Start date
2020-12-28
Completion date
2026-05-26
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, Radionecrosis, Radiotherapy, Sensitivity

Keywords

Diffusional variance decomposition, DIVIDE, Brain metastasis, Radiation treatment, Treatment response, Radionecrosis, Radiation damage, Radiation sensitivity, Magnetic resonance imaging

Brief 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 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.

Interventions

RADIATIONBrain metastases radiation

Brain metastases radiation according to clinical practice.

Sponsors

Lund University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients prescribed stereotactic radiation therapy to the brain, where MRI imaging is included in the treatment preparations. 2. Cohesive remaining solid tumor component of ≥10mm. 3. Age ≥18 years. 4. World Health Organisation (WHO) performance status 0-1.

Exclusion criteria

1. Inability to decide for oneself on participation in the study. 2. Inability to understand the Swedish language. 3. Metastases close to the base of the skull. 4. Contraindications to conducting an MRI examination. 5. Contraindications to obtaining contrast media during MRI examination. 6. Expected survival less than 6 months. 7. Previous radiation treatment to the same site in the brain, i.e. current treatment is a rope radiation. \-

Design outcomes

Primary

MeasureTime frameDescription
Grade of radiation sensitivity to brain metastasis.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.
Early changes in the tumor during and after completion of radiation therapy.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.
Changes linked to treatment responses.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.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026