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

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

Study Overview

• Status: Recruiting
• Conditions: Brain Metastases; Radiotherapy; Sensitivity; Radionecrosis
• Intervention / Treatment: Radiation: Brain metastases radiation

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Alkner, MD, PhD; Phone Number: +46 46 17 75 20; Email: sara.alkner@med.lu.se
• Study Contact Backup: Name: Minn Lerner, Radiation physicist; Phone Number: +46 46 17 56 83; Email: minna.lerner@skane.se

Study Locations

• Sweden
  • Lund, Sweden, 221 85
    • Recruiting
    • Lund University Hospital
    • Contact: Sara Alkner, MD, PhD; Phone Number: +46 46 17 75 20; Email: sara.alkner@med.lu.se
    • Contact: Minna Lerner, Radiation physict; Phone Number: +46 46 17 56 83; Email: minna.lerner@skane.se
    • Principal Investigator: Sara Alkner, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Radiation: Brain metastases radiation; Brain metastases radiation according to clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of radiation sensitivity to brain metastasis.	Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.	Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Grade of radiation sensitivity to brain metastasis.	Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.	Is evaluated after 3 months after end of treatment.
Grade of radiation sensitivity to brain metastasis.	Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.	Is evaluated after 6 months after end of treatment.
Early changes in the tumor during and after completion of radiation therapy.	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.	Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Early changes in the tumor during and after completion of radiation therapy.	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.	Is evaluated after 3 months after end of treatment.
Early changes in the tumor during and after completion of radiation therapy.	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.	Is evaluated after 6 months after end of treatment.
Changes linked to treatment responses.	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.	Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Changes linked to treatment responses.	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.	Is evaluated after 3 months after end of treatment.
Changes linked to treatment responses.	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.	Is evaluated after 6 months after end of treatment.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.	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.	Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.	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.	Is evaluated after 3 months after end of treatment.
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.	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.	Is evaluated after 6 months after end of treatment.

Collaborators and Investigators

• Sponsor: Lund University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Treatment response; Radiation treatment; Brain metastasis; Radionecrosis; Diffusional variance decomposition; DIVIDE; Radiation damage; Radiation sensitivity
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Hypersensitivity; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: MR-SRS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No