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

NCT05095766 | Completed

• 1 other identifier: 2017-1488
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

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

Adults with brain metastases undergoing MRI

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Université de Sherbrooke: collaborator

Study Sites (1)

CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Brain Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: November 23, 2017
• Primary Completion: April 30, 2022
• Study Completion: February 13, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)