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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000306-38 | EudraCT Number |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNS lymphoma patients | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG | Diagnostic Test | PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øystein Risa, phd | Norwegian University of Science and Technology, Department of Circulation and Medical Imaging | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian University of Science and Technology, Department of Circulation and Medical Imaging | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38748286 | Derived | 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. |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 18F-fluciclovine | Diagnostic Test | PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment. |
|
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| standard MRI | Diagnostic Test | clinical routine MRI examination, both for primary staging and response to therapy assessment. |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |