Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

Brain Tumor Clinical Trial

Official title:

Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03394716
• Other study ID #: N17MRB
• Status: Terminated
• Start date: January 12, 2018
• Est. completion date: December 10, 2020

Study information

• Verified date: April 2021
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Radiation:
• Radiotherapy
standard radiotherapy treatment with 1-3 extra MRIs

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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