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

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ClinicalTrials.gov Identifier: NCT04700748
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Radiotherapy Brain Metastases Sensitivity Radionecrosis Radiation: Brain metastases radiation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diffusion-weighted MRI to Predict Treatment Response in Stereotactic Radiotherapy of CNS Metastases
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700748


Contacts
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Contact: Sara Alkner, MD, PhD +46 46 17 75 20 sara.alkner@med.lu.se
Contact: Minn Lerner, Radiation physicist +46 46 17 56 83 minna.lerner@skane.se

Locations
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Sweden
Lund University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Sara Alkner, MD, PhD    +46 46 17 75 20    sara.alkner@med.lu.se   
Contact: Minna Lerner, Radiation physict    +46 46 17 56 83    minna.lerner@skane.se   
Principal Investigator: Sara Alkner, MD, PhD         
Sponsors and Collaborators
Lund University Hospital
More Information
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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT04700748    
Other Study ID Numbers: MR-SRS-001
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University Hospital:
Diffusional variance decomposition
DIVIDE
Brain metastasis
Radiation treatment
Treatment response
 Radionecrosis
Radiation damage
Radiation sensitivity
Magnetic resonance imaging
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Hypersensitivity
Neoplastic Processes
 Neoplasms
Pathologic Processes
Immune System Diseases