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

Not Applicable

• Conditions: Brain Metastases; Sensitivity; Radionecrosis; Radiotherapy
• Interventions: Radiation: Brain metastases radiation

• Registration Number: NCT04700748
• Lead Sponsor: Lund University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-28
• Study First Submitted: 2020-12-28
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diffusion-weighted MRI to predict treatment response in stereotactic radiotherapy of CNS metastases.	Brain metastases radiation	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.

Primary Outcome Measures

Name	Time	Method
Early changes in the tumor during and after completion of radiation therapy.	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.	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.	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.	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.

Trial Locations

Locations (1)

Lund University Hospital; 🇸🇪 Lund, Sweden