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

NCT ID: NCT03188354

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2023-12-31

Brief 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.

Conditions

Lymphoma, Non-Hodgkin; Central Nervous System Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CNS lymphoma patients

Patients included in the study will be examined with both 18F-FDG and 18F-Fluciclovine as well as standard MRI in the PET/MRI scanner on two consecutive days, both in primary staging and for therapy assessment

Group Type: EXPERIMENTAL

18F-FDG

Intervention Type: DIAGNOSTIC_TEST

PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.

18F-fluciclovine

Intervention Type: DIAGNOSTIC_TEST

PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.

standard MRI

Intervention Type: DIAGNOSTIC_TEST

clinical routine MRI examination, both for primary staging and response to therapy assessment.

Interventions

18F-FDG

PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.

Intervention Type: DIAGNOSTIC_TEST

18F-fluciclovine

PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.

Intervention Type: DIAGNOSTIC_TEST

standard MRI

clinical routine MRI examination, both for primary staging and response to therapy assessment.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Fluorine-18 Fluorodeoxyglucose; amino-acid PET-tracer; Magnetic resonance imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Øystein Risa, phd

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, Department of Circulation and Medical Imaging

Locations

Norwegian University of Science and Technology, Department of Circulation and Medical Imaging

Trondheim, , Norway

Countries

Norway

References

Husby T, Johannessen K, Berntsen EM, Johansen H, Giskeodegard GF, Karlberg A, Fagerli UM, Eikenes L. 18F-FACBC and 18F-FDG PET/MRI in the evaluation of 3 patients with primary central nervous system lymphoma: a pilot study. EJNMMI Rep. 2024 Jan 31;8(1):2. doi: 10.1186/s41824-024-00189-6.

Reference Type: DERIVED

PMID: 38748286 (View on PubMed)

Other Identifiers

2017-000306-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PET/MRI_CNS_LYMPHOMA

Identifier Type: -

Identifier Source: org_study_id