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

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04700748
• Other study ID #: MR-SRS-001
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: Lund University Hospital
• Contact: Sara Alkner, MD, PhD
• Phone: +46 46 17 75 20
• Email: sara.alkner[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Brain Metastases
• Hypersensitivity
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Radionecrosis
• Radiotherapy
• Sensitivity

Intervention

Radiation:
• Brain metastases radiation
Brain metastases radiation according to clinical practice.

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.