Skip to main content
OpenTrials
Completed

NCT Number: NCT04700748

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiotherapy Brain Diseases Brain Metastases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Hypersensitivity Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Radionecrosis Sensitivity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University Hospital

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Brain metastases radiation

Radiation

Brain metastases radiation according to clinical practice.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Jan 8, 2021
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.