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Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03394716
Enrollment
45
Registered
2018-01-09
Start date
2018-01-12
Completion date
2020-12-10
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor

Keywords

MRI, Radiotherapy

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.

Interventions

RADIATIONRadiotherapy

standard radiotherapy treatment with 1-3 extra MRIs

Sponsors

The Netherlands Cancer Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MRI parameters in the target volumethrough study completion, an average of 3 yearsfunctional 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 volumethrough study completion, an average of 3 yearsThe 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

MeasureTime frameDescription
the correlation between MRI parameters to the treatment outcomethrough study completion, an average of 3 yearsto make a sample size calculation for a future study of imaging marker discovery.
the correlation between anatomical variations and the treatment outcomethrough study completion, an average of 3 yearsto make a sample size calculation for a future study of imaging marker discovery.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026