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

NCT ID: NCT04700748

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-28
• Study Completion Date: 2023-12-31

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.

Conditions

Radiotherapy; Brain Metastases; Sensitivity; Radionecrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diffusion-weighted MRI to predict treatment response in stereotactic radiotherapy of CNS metastases.

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.

Group Type: OTHER

Brain metastases radiation

Intervention Type: RADIATION

Brain metastases radiation according to clinical practice.

Interventions

Brain metastases radiation

Brain metastases radiation according to clinical practice.

Intervention Type: RADIATION

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.

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lund University Hospital

Lund, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Sara Alkner, MD, PhD

Role: CONTACT

sara.alkner@med.lu.se

+46 46 17 75 20

Minn Lerner, Radiation physicist

Role: CONTACT

minna.lerner@skane.se

+46 46 17 56 83

Facility Contacts

Sara Alkner, MD, PhD

Role: primary

sara.alkner@med.lu.se

+46 46 17 75 20

Minna Lerner, Radiation physict

Role: backup

minna.lerner@skane.se

+46 46 17 56 83

Other Identifiers

MR-SRS-001

Identifier Type: -

Identifier Source: org_study_id