Lymphoma, Non-HodgkinNCT03188354
Diagnostic Assessment of 18F-fluciclovine and 18F-FDG -PET/MRI of Primary Central Nervous System Lymphoma
A study testing 18F-FDG, 18F-fluciclovine and standard MRI in people with Lymphoma, Non-Hodgkin and Central Nervous System Neoplasms, run by Norwegian University of Science and Technology at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Central Nervous System Neoplasms
- What is being tested?
- 18F-FDG, 18F-fluciclovine and standard MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2017to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of PCNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy
- Written informed consent from patient or guardian
- Immunocompetent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
Trondheim
About this study
Official title: Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma
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.
Read more
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.
- Being tested
- 18F-FDG, 18F-fluciclovine, standard MRI
- Keywords
- Positron-Emission Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Lymphoma, Non-Hodgkin, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDiagnostic test
Also called Fluorine-18 Fluorodeoxyglucose
PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
18F-fluciclovineDiagnostic test
Also called amino-acid PET-tracer
PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
standard MRIDiagnostic test
Also called Magnetic resonance imaging
clinical routine MRI examination, both for primary staging and response to therapy assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: 18F-FDG; Diagnostic Test: 18F-fluciclovine; Diagnostic Test: standard MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans
of combined 18F-Fluciclovine-PET/MRI examination in comparison with the clinical routing MRI examination
Measured: 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
Measured: 2 days
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Øystein Risa, phd, Study director, Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188354
- Sponsor's protocol ID
- PET/MRI_CNS_LYMPHOMA
- Other IDs
- 2017-000306-38, 2017
- Status last verified
- Jan 2024
- First submitted
- 13 Jun 2017
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38748286
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Assessment of 18F-fluciclovine and 18F-FDG - PET/MRI of Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT03188354
- Acronym / sponsor ID
- PET/MRI_CNS_LYMPHOMA
- Keywords
- Positron-Emission Tomography, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNS lymphoma patients | Experimental | Diagnostic Test: 18F-FDG, Diagnostic Test: 18F-fluciclovine, Diagnostic Test: standard MRIPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological diagnosis of PCNSL based on cytology/flow cytometry of cerebrospinal fluid (CSF) or brain biopsy
- Written informed consent from patient or guardian
- Immunocompetent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDGAlso: Fluorine-18 FluorodeoxyglucosePET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment. | Diagnostic test | CNS lymphoma patients |
| 18F-fluciclovineAlso: amino-acid PET-tracerPET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment. | Diagnostic test | CNS lymphoma patients |
| standard MRIAlso: Magnetic resonance imagingclinical routine MRI examination, both for primary staging and response to therapy assessment. | Diagnostic test | CNS lymphoma patients |
Primary outcome
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
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
1 secondary outcome
prediction of progression-free survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 38748286Husby 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øystein Risa, phd study director
Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG, 18F-fluciclovine and standard MRI in people with Lymphoma, Non-Hodgkin and Central Nervous System Neoplasms, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of 18F-Fluciclovine-PET/MRI sans (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.