Clinical trial NCT04700748: Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of Central Nervous System (CNS) Metastases
Official title: Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of CNS Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy
Brain Metastases
Sensitivity
Radionecrosis
Keywords: Diffusional variance decomposition
DIVIDE
Brain metastasis
Radiation treatment
Treatment response
Radionecrosis
Radiation damage
Radiation sensitivity
Magnetic resonance imaging
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

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Primary outcomes:
measure: Grade of radiation sensitivity to brain metastasis.
timeFrame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
measure: Grade of radiation sensitivity to brain metastasis.
timeFrame: Is evaluated after 3 months after end of treatment.
measure: Grade of radiation sensitivity to brain metastasis.
timeFrame: Is evaluated after 6 months after end of treatment.
measure: Early changes in the tumor during and after completion of radiation therapy.
timeFrame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
measure: Early changes in the tumor during and after completion of radiation therapy.
timeFrame: Is evaluated after 3 months after end of treatment.
measure: Early changes in the tumor during and after completion of radiation therapy.
timeFrame: Is evaluated after 6 months after end of treatment.
measure: Changes linked to treatment responses.
timeFrame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
measure: Changes linked to treatment responses.
timeFrame: Is evaluated after 3 months after end of treatment.
measure: Changes linked to treatment responses.
timeFrame: Is evaluated after 6 months after end of treatment.
measure: Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
timeFrame: Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
measure: Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
timeFrame: Is evaluated after 3 months after end of treatment.
measure: Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
timeFrame: Is evaluated after 6 months after end of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
References: