Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Brain Tumor
• Intervention / Treatment: Radiation: Radiotherapy

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066CX
      • Antoni van Leeuwenhoek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with metastasis in the brain from extracranial solid tumors or patients with primary brain tumors who will be treated with fractionated radiotherapy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient brain tumor treated with fractionated radiotherapy	Radiation: Radiotherapy; standard radiotherapy treatment with 1-3 extra MRIs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI parameters in the target volume	functional MRI parameters (permeability, perfusion and diffusion) in the target volume before and during fractional radiotherapy treatment	through study completion, an average of 3 years
anatomical variations in position, shape and size in the target volume	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.	through study completion, an average of 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2018
• Primary Completion (ACTUAL): December 10, 2020
• Study Completion (ACTUAL): December 10, 2020

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (ACTUAL): January 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: MRI; Radiotherapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: N17MRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No