Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

NCT03394716 | Terminated

• 1 other identifier: N17MRB
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

MRI; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• the correlation between MRI parameters to the treatment outcome

  through study completion, an average of 3 years

• the correlation between anatomical variations and the treatment outcome

  through study completion, an average of 3 years

Study Arms (1)

Patient brain tumor treated with fractionated radiotherapy

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

standard radiotherapy treatment with 1-3 extra MRIs

Patient brain tumor treated with fractionated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066CX, Netherlands

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: January 9, 2018
• Study Start: January 12, 2018
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)