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Trial record 31 of 156 for:    "Primary Central Nervous System Lymphoma"

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

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ClinicalTrials.gov Identifier: NCT03188354
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.


Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Central Nervous System Neoplasms Diagnostic Test: 18F-FDG Diagnostic Test: 18F-fluciclovine Diagnostic Test: standard MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: 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
Diagnostic Test: 18F-FDG
PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
Other Name: Fluorine-18 Fluorodeoxyglucose

Diagnostic Test: 18F-fluciclovine
PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
Other Name: amino-acid PET-tracer

Diagnostic Test: standard MRI
clinical routine MRI examination, both for primary staging and response to therapy assessment.
Other Name: Magnetic resonance imaging




Primary Outcome Measures :
  1. sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans [ Time Frame: 2 days ]
    of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination

  2. sensitivity and specificity of 18F-FDG-PET/MRI scans [ Time Frame: 2 days ]
    of combined 18F-FDG-PET/MRI examination in comparison with the clinical routing MRI examination


Secondary Outcome Measures :
  1. prediction of progression-free survival [ Time Frame: 1 year ]
    which PET/MRI parameters that are best suited as an imaging biomarker for response evaluation and for progression-free survival at 12 months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188354


Contacts
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Contact: Live Eikenes, phd ++47 73551534 live.eikenes@ntnu.no
Contact: Trine Husby, md trine.husby@ntnu.no

Locations
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Norway
Norwegian University of Science and Technology, Department of Circulation and Medical Imaging Recruiting
Trondheim, Norway
Contact: Live Eikenes, phd       live.eikenes@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Øystein Risa, phd Norwegian University of Science and Technology, Department of Circulation and Medical Imaging

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03188354     History of Changes
Other Study ID Numbers: PET/MRI_CNS_LYMPHOMA
2017-000306-38 ( EudraCT Number )
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Positron-Emission Tomography
Magnetic Resonance Imaging

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Nervous System Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action