NCT04700748

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 28, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

December 28, 2020

Last Update Submit

January 5, 2021

Conditions

RadiotherapyBrain MetastasesSensitivityRadionecrosis

Keywords

Diffusional variance decompositionDIVIDEBrain metastasisRadiation treatmentTreatment responseRadionecrosisRadiation damageRadiation sensitivityMagnetic resonance imaging

Outcome Measures

Primary Outcomes (12)

  • 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.

Study Arms (1)

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

OTHER

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

Interventions

Brain metastases radiationRADIATION

Brain metastases radiation according to clinical practice.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital

Lund, 221 85, Sweden

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsHypersensitivity

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesImmune System Diseases

Central Study Contacts

Sara Alkner, MD, PhD

CONTACT

+46 46 17 75 20sara.alkner@med.lu.se

Minn Lerner, Radiation physicist

CONTACT

+46 46 17 56 83minna.lerner@skane.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 8, 2021

Study Start

December 28, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)