Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

Terminated

• Conditions: Brain Tumor
• Interventions: Radiation: Radiotherapy

• Registration Number: NCT03394716
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

This study aims to evaluate anatomical and functional changes during RT for patients receiving fractionated RT for brain tumors. Anatomical changes during RT will be registered and analyzed and if needed the radiotherapy plan will be modified for the individual patient. This means that the "to be irradiated volume" will be modified according to the shape changes of the tumor. The functional MRI sequences will be used to evaluate what parameters, and at which time point, are important for radiotherapy outcome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Study Start: 2018-01-12
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Primary brain tumor (WHO IV, GBM); treated with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.
• Brain metastasis (from a solid extracranial tumor) eligible for treatment with fractionated radiotherapy with or without preceding surgery. Systemic treatment is allowed before and during radiotherapy.

Also, postoperative patients with a macroscopic residual tumor lesion can be included (the diagnosis of residual diseases is defined by the treating neurosurgeon or on the MRI executed within 24 hours after the surgery, the diagnosis of residual macroscopic disease should always be confirmed during the neuro-oncology multidisciplinary meeting).

Exclusion Criteria

• Patients receiving Whole Brain RT (WBRT)
• Patient with a poor kidney function (GFR < 30 mL/min; CKD 4 and 5; patients on dialysis and patients with acute kidney insufficiency)
• None, doubtful or very small (<5 mm in its largest dimension) contrast enhancing lesion
• Patients with a contraindication for MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient brain tumor treated with fractionated radiotherapy	Radiotherapy	-

Primary Outcome Measures

Name	Time	Method
MRI parameters in the target volume	through study completion, an average of 3 years	functional MRI parameters (permeability, perfusion and diffusion) in the target volume before and during fractional radiotherapy treatment
anatomical variations in position, shape and size in the target volume	through study completion, an average of 3 years	The difference is position shape and size in the target volume before and during fractional radiotherapy treatment. In case there is no macroscopic extension beyond the clinical target volume the new target volumes (gross target volume (GTV) and clinical target volume (CTV).) will also (but later) be delineated for analysis of volume changes, center of mass changes and distance measurements between the delineation on planning MRI versus repeated MRI.

Secondary Outcome Measures

Name	Time	Method
the correlation between MRI parameters to the treatment outcome	through study completion, an average of 3 years	to make a sample size calculation for a future study of imaging marker discovery.
the correlation between anatomical variations and the treatment outcome	through study completion, an average of 3 years	to make a sample size calculation for a future study of imaging marker discovery.

Trial Locations

Locations (1)

Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, Noord-Holland, Netherlands