Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188354
• Other study ID #: PET/MRI_CNS_LYMPHOMA
• Secondary ID: 2017-000306-38
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary central nervous system lymphoma (PCNSL) is a rare subtype of extranodal non-Hodgkins Lymphoma (NHL) with rising incidence and variable response to treatment. MRI is considered the most useful imaging modality of PCNSL, but conventional MRI has its limitations, and contrast-enhanced MRI sometimes does not clearly differentiate PCNSL from other neoplasm or non-neoplastic diseases.

Positron emission tomography (PET) could have a number of potential advantages in refining and improving the management of patients with PCNSL. Because of the rare incidence of PCNSL, the value of PET has however not been well defined in this subtype of lymphomas. There are a few studies that have investigated the role for FDG-PET and amino acid PET in the primary staging/diagnosis and response assessment in PCNSL patients, but the results are inconclusive. Further studies are therefore needed.

Previous studies support an integration of both MRI and PET for the routine diagnostic workup and response assessment for PCNSL, and the newly available simultaneous PET/MRI scanners may have the potential to improve imaging baseline accuracy, response assessment and add prognostic value in PCNSL.

The main aim of the study is to compare the sensitivity and specificity of a combined PET/MRI examination with the clinical routine MRI examination given to these patients today. It will be investigated whether PET (18F-FDG and 18F-fluciclovine) can provide additional prognostic value at baseline and in response assessment compared to MRI and established pre-treatment prognostic scores in PCNSL, and evaluate which PET/MRI parameters that are best suited as an imaging biomarker for progression-free survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological diagnosis of PCNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy

• Written informed consent from patient or guardian

• Immunocompetent

Exclusion Criteria:

• Previous chemotherapy

• Contra-indications for MRI (Pacemakers, defibrillators, aneurysm clips, any form of metal in the body, or severe claustrophobia)

• Hypersensitivity to either 18F-Fluciclovine or 18F-FDG or to any of the excipients

• Pregnancy (pregnancy test for all women in fertile age)

• Breastfeeding

• Weight > 120 kg

• Estimated glomerular filtration rate (eGFR) <30ml/min/1,73m2

• HIV-positive

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Lymphoma
• Lymphoma, Non-Hodgkin
• Nervous System Neoplasms

Intervention

Diagnostic Test:
• 18F-FDG
PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
• 18F-fluciclovine
PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
• standard MRI
clinical routine MRI examination, both for primary staging and response to therapy assessment.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology, Department of Circulation and Medical Imaging	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans	of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination	2 days
Primary	sensitivity and specificity of 18F-FDG-PET/MRI scans	of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination	2 days
Secondary	prediction of progression-free survival	which PET/MRI parameters that are best suited as an imaging biomarker for response evaluation and for progression-free survival at 12 months	1 year