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Clinical Trials/NCT04700748
NCT04700748
Unknown
Not Applicable

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

Lund University Hospital1 site in 1 country150 target enrollmentDecember 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radiotherapy
Sponsor
Lund University Hospital
Enrollment
150
Locations
1
Primary Endpoint
Early changes in the tumor during and after completion of radiation therapy.
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 28, 2020
End Date
December 31, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

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.

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 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.

Study Sites (1)

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