Clinical trial NCT05095766: Comparaison Between MRI Alone or Combined With Positron Emission Tomography for Brain Metastasis Diagnosis
Official title: Differentiation Between Radionecrosis and Tumor Recurrence for Post-stereotactic Radiosurgery Follow-up by Pharmacokinetic Analyses in Perfusion MRI and Positron Emission Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Metastases, Adult
Keywords: Magnetic resonance imaging
Radiofrequency
Radionecrosis
Tumor recurrence
Post-stereotactic surgery
Positron emission tomography
CT scan
18F-fluoroethyl-tyrosine
Perfusion MRI
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Université de Sherbrooke
First posted: 2021-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with brain metastases undergoing MRI

Brief summary: During gamma scalpel treatment of brain tumors and metastases, a follow-up magnetic resonance imaging (MRI) scan is performed. The radiologist who reviews the MRI assesses whether there is an increase in signal at the tumor site. This increase potentially indicates that the treatment was not effective. However, in 25% of cases (one in four people), this signal enhancement is not due to ineffective treatment, but to inflammation (swelling/damage) and tissue death around the tumor. This is why when an increase in signal is detected, additional follow-up is essential. The standard additional follow-up has an accuracy of about 83%.

This is an observational study on patients with brain metastatis comparing MRI alone or combined to PET-FET to improve accuracy of diagnosis of metastasis recurrence.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years of age;
* Having undergone gamma knife radiosurgery for brain metastasis;
* Presenting for a first MRI follow-up (Cohort C1);
* Presence of one or more brain metastases with increased enhancement on follow-up MRI (Cohort C2.1 and C2.2); A participant recruited for Cohort C1 could be recruited for follow-up in Cohort C2.1 or C2.2 if the MRI result is ambiguous.

Exclusion Criteria:

* Pregnancy or breastfeeding;
* Other condition that may influence the imaging result;
* Renal impairment (\<30 mL/min/1.73 m2). This threshold is consistent with recent RAC recommendations; Note: For participants with intermediate renal clearance (30-60 mL/min/1.73 m2), the total gadobutrol dose injected is set at the manufacturer's recommended clinical dose. For patients with renal clearance greater than 60 mL/min/1.73 m2, a dose of 1.5x the normal dose is used. These dose values have been approved by Dr. Chénard and are consistent with the RAC recommendations.
* Inability to maintain supine position for the required duration (variable, depending on the sequence);
* Patients who have previously received full brain irradiation;
* Patients who are claustrophobic and cannot tolerate insertion into the MRI scanner;

Primary outcomes:
measure: Comparison of novel MRI method with current MRI exam method
timeFrame: Following MRI exam
measure: Comparison of DCE-MRI method with FET PET
timeFrame: Following MRI exam
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-CHUS
state: Quebec
Study officials:
References: