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

Primary Purpose

Radiotherapy, Brain Metastases, Sensitivity

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Brain metastases radiation
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Radiotherapy focused on measuring Diffusional variance decomposition, DIVIDE, Brain metastasis, Radiation treatment, Treatment response, Radionecrosis, Radiation damage, Radiation sensitivity, Magnetic resonance imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Lund University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2020
Last Updated
January 5, 2021
Sponsor
Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04700748
Brief Title
Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of Central Nervous System (CNS) Metastases
Official Title
Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of CNS Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy, Brain Metastases, Sensitivity, Radionecrosis
Keywords
Diffusional variance decomposition, DIVIDE, Brain metastasis, Radiation treatment, Treatment response, Radionecrosis, Radiation damage, Radiation sensitivity, Magnetic resonance imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diffusion-weighted MRI to predict treatment response in stereotactic radiotherapy of CNS metastases.
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Brain metastases radiation
Intervention Description
Brain metastases radiation according to clinical practice.
Primary Outcome Measure Information:
Title
Grade of radiation sensitivity to brain metastasis.
Description
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Time Frame
Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Title
Grade of radiation sensitivity to brain metastasis.
Description
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Time Frame
Is evaluated after 3 months after end of treatment.
Title
Grade of radiation sensitivity to brain metastasis.
Description
Evaluation done by MRI to see whether radiation sensitivity can be measured during radiotherapy and after 3 and 6 months after end of treatment.
Time Frame
Is evaluated after 6 months after end of treatment.
Title
Early changes in the tumor during and after completion of radiation therapy.
Description
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.
Time Frame
Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Title
Early changes in the tumor during and after completion of radiation therapy.
Description
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.
Time Frame
Is evaluated after 3 months after end of treatment.
Title
Early changes in the tumor during and after completion of radiation therapy.
Description
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.
Time Frame
Is evaluated after 6 months after end of treatment.
Title
Changes linked to treatment responses.
Description
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.
Time Frame
Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Title
Changes linked to treatment responses.
Description
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.
Time Frame
Is evaluated after 3 months after end of treatment.
Title
Changes linked to treatment responses.
Description
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.
Time Frame
Is evaluated after 6 months after end of treatment.
Title
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Description
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.
Time Frame
Is evaluated after end of radiotherapy, that is after 3 days, as all subjects receive 3x10 Gy.
Title
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Description
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.
Time Frame
Is evaluated after 3 months after end of treatment.
Title
Differentiate between radiation damage (radionecrosis) and residual / recurrent tumor.
Description
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.
Time Frame
Is evaluated after 6 months after end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Alkner, MD, PhD
Phone
+46 46 17 75 20
Email
sara.alkner@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Minn Lerner, Radiation physicist
Phone
+46 46 17 56 83
Email
minna.lerner@skane.se
Facility Information:
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Alkner, MD, PhD
Phone
+46 46 17 75 20
Email
sara.alkner@med.lu.se
First Name & Middle Initial & Last Name & Degree
Minna Lerner, Radiation physict
Phone
+46 46 17 56 83
Email
minna.lerner@skane.se
First Name & Middle Initial & Last Name & Degree
Sara Alkner, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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