Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

NCT ID: NCT03394716

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-12

Study Completion Date

2020-12-10

Brief Summary

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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

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Conditions

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Brain Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient brain tumor treated with fractionated radiotherapy

Radiotherapy

Intervention Type RADIATION

standard radiotherapy treatment with 1-3 extra MRIs

Interventions

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Radiotherapy

standard radiotherapy treatment with 1-3 extra MRIs

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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N17MRB

Identifier Type: -

Identifier Source: org_study_id

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