Comparaison Between MRI Alone or Combined With Positron Emission Tomography for Brain Metastasis Diagnosis

Brain Metastases, Adult Clinical Trial

— ITIRR  

Official title:

Differentiation Between Radionecrosis and Tumor Recurrence for Post-stereotactic Radiosurgery Follow-up by Pharmacokinetic Analyses in Perfusion MRI and Positron Emission Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05095766
• Other study ID #: 2017-1488
• Status: Active, not recruiting
• Start date: November 23, 2017
• Est. completion date: November 23, 2024

Study information

• Verified date: January 2023
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 23, 2024
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Brain Metastases, Adult
• Brain Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
Canada	CIUSSS de l'Estrie-CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of novel MRI method with current MRI exam method	In the context of differentiating radionecrosis and recurrence of metastasis: Is our new method better than the actual standard of care in Sherbrooke?	Following MRI exam
Primary	Comparison of DCE-MRI method with FET PET	In the context of differentiating radionecrosis and recurrence of metastasis: is one better than the other? And Can DCE-MRI and FET PET be combined to differentiate between recurrence/radionecrosis?	Following MRI exam