Primary Central Nervous System LymphomaPhase 1FLUDALOCNCT05390814
[18F]-Fludarabine PET/MRI in Primary Central Nervous System Lymphoma
A Phase 1 study testing PET-MRI in people with Primary Central Nervous System Lymphoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Primary central nervous system (CNS) lymphomas represent 5% of primary brain tumors. More than 90% of them are diffuse large B-cell lymphomas. [18F]-Fluorodeoxyglucose positron emission tomography (PET-[18F]-FDG) is the gold standard for imaging systemic lymphomas, but its application in primary CNS lymphoma is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- PET-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2023to 5 Dec 2024
- Phase
- Phase 1
- 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
- Patients aged ≥ 18 years
- Diagnosis of newly diagnosed high-grade CNS lymphoma (with histological and/or cytological confirmation)
- Patient naive to chemotherapy, or radiotherapy treatment for CNS lymphoma
- Contrast-enhanced intracranial mass greater than or equal to 1 cm longest axis
- Karnofsky index ≥ 40
- No systemic lymphoma on [18F]-FDG PET/CT
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- Creatinine clearance ≥ 30 mL/min
- Social security affiliation (excluding AME)
- Signature of the informed consent by the patient or by a legal representative or the close relative if the patient is not able to do so
Who cannot join
- Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F]-Fludarabine
- Previous treatment for primary central nervous system lymphoma
- Isolated primary vitro-retinal lymphoma
- Isolated CNS relapse of a systemic lymphoma
- Other active cancer except basal cell carcinoma of the skin and/or cervical cancer in situ
- Immunosuppression (organ transplant in particular)
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- Positive HIV serology
- Presence of another progressive pathology that is life-threatening in the short term
- Treatment with dipyridamole
- History of allergy to gadolinium chelates (DOTAREM®)
- Absolute contraindication to MRI (pacemaker, cochlear implant ...), to the administration of gadolinium
- Patient of childbearing potential without effective contraception, breastfeeding or pregnant
- Severe cognitive impairment incompatible with good cooperation in the PET-MRI examination
- Patient with pain or restlessness unable to remain motionless in supine position for 60 minutes
- Weight > 100 Kg
- Patient deprived of liberty or under legal protection (guardianship or curatorship)
- Ongoing participation in another interventional research protocol. Participation in research of a non-interventional type is authorized.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study
Primary central nervous system (CNS) lymphomas represent 5% of primary brain tumors. More than 90% of them are diffuse large B-cell lymphomas.
[18F]-Fluorodeoxyglucose positron emission tomography (PET-[18F]-FDG) is the gold standard for imaging systemic lymphomas, but its application in primary CNS lymphoma is compromised by the limited specificity of brain fixations and the high uptake of [18F]-FDG in healthy brain tissue.
Read more
[18F]-Fludarabine is a new radiopharmaceutical developed for PET imaging of lymphomas. Preclinical studies indicate a restricted binding specificity to lymphoid tissue compared to [18F]-FDG and an ability to detect residual lymphoma disease after treatment. A pilot study in humans shows good agreement of its binding with tumor sites in systemic lymphoma and superior tumor contrast to [18F]-FDG. Finally, a recent preclinical study shows a binding ratio in brain lymphoma 3 times higher than that of healthy brain tissue in mouse models of primary CNS lymphoma, whereas in mouse models of high-grade glial tumors, the binding level is very low, comparable to that of healthy tissue (background). Investigators hypothesize that [18F]-Fludarabine could be the radiopharmaceutical of choice for the diagnosis and monitoring of primary CNS lymphomas in PET.
The main objective of the study is to characterize the cerebral distribution and [18F]-Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET-MR imaging.
Read the detailed description
Monocenter, open, uncontrolled and non-randomized pilot study designed to evaluate the uptake of [18F]-Fludarabine in 16 patients with newly diagnosed CNS lymphoma at initial diagnosis, before treatment using hybrid PET/MR system.
Main objective: to characterize the brain distribution and tumoral uptake in CNS lymphoma before treatment. The secondary objectives are to compare PET-[18F]-Fludarabine results with those of morphological MRI with and without gadolinium injection, diffusion and perfusion MRI, proton-spectroscopy, histological or cytological diagnosis, and brain [18F]-FDG PET imaging.
Patient screening includes a clinical and neurological examination, diagnostic MRI, biological examination, [18F]-FDG PET examination to exclude systemic lymphoma, histological/cytological diagnosis of brain lymphoma. Once informed consent is obtained, one brain PET with [18F]-Fludarabine (4 MBq/kg) combined with simultaneous multiparametric MR sequences is scheduled.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- PET-MRI
- Keywords
- [18F]-Fludarabine, PET-MRI, Primary Central Nervous System Lymphomas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRIDrug
[18F]-Fludarabine imaging in the diagnostic workup of primary central nervous system lymphomas: a PET-MRI pilot study
| Study group | Role | What they receive |
|---|---|---|
| PET-RMI | Experimental | Not described Receives: Drug: PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of [18F]-Fludarabine uptake in tumoral lesions and normal tissue using SUV, tumor/normal tissues ratios
Standardized measurement of [18F]-Fludarabine uptake (SUV) in tumor will be done on PET imaging superimposed on post gadolinium MRI.
Measured: 15 days
Secondary outcomes (7)
Cerebral distribution of [18F]-Fludarabine in healthy and tumoral tissues
[18F]-Fludarabine time activity curves will be generated in normal and tumoral tissues with dynamic PET acquisition
Measured: 15 days
Temporal activity curves of [18F]-Fludarabine in healthy and tumoral tissues
[18F]-Fludarabine time activity curves will be generated in normal and tumoral tissues with dynamic PET acquisition
Measured: 15 days
Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG
Tumoral uptake in [18F]-FDG brain PET and brain [18F]-Fludarabine will be compared as well as contrast to normal uptake
Measured: 15 days
Volumes of contrast enhancement in post-gadolinium T1-weighted MR sequence
Tumor uptake delimitation will be compared to contrast enhancement limits
Measured: 15 days
Hypersignal in diffusion-weighted sequence and apparent diffusion coefficient (ADC)
Tumor volume on brain PET will be compared to hypersignal volume on T2-weighted FLAIR sequence
Measured: 15 days
Tumor perfusion, capillary permeability in perfusion weighted MRI
[18F]-Fludarabine uptake in tumor will be analyzed in light of tumor perfusion on PET superimposed on perfusion sequence
Measured: 15 days
Metabolite ratios in spectroscopy
[18F]-Fludarabine uptake in tumor will be analyzed in light of metabolites profile in proton-spectroscopy
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start18 Dec 2023
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie KAS, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390814
- Sponsor's protocol ID
- P160407
- Other IDs
- 2021-005193-26
- Acronym
- FLUDALOC
- Status last verified
- Aug 2025
- First submitted
- 20 May 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study
- ClinicalTrials.gov ID
- NCT05390814
- Acronym / sponsor ID
- FLUDALOC / P160407
- Conditions
- Primary Central Nervous System Lymphoma
- Keywords
- [18F]-Fludarabine, PET-MRI, Primary Central Nervous System Lymphomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 25 May 2022 (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 (CNS) lymphomas represent 5% of primary brain tumors. More than 90% of them are diffuse large B-cell lymphomas.
[18F]-Fluorodeoxyglucose positron emission tomography (PET-[18F]-FDG) is the gold standard for imaging systemic lymphomas, but its application in primary CNS lymphoma is compromised by the limited specificity of brain fixations and the high uptake of [18F]-FDG in healthy brain tissue.
[18F]-Fludarabine is a new radiopharmaceutical developed for PET imaging of lymphomas. Preclinical studies indicate a restricted binding specificity to lymphoid tissue compared to [18F]-FDG and an ability to detect residual lymphoma disease after treatment. A pilot study in humans shows good agreement of its binding with tumor sites in systemic lymphoma and superior tumor contrast to [18F]-FDG. Finally, a recent preclinical study shows a binding ratio in brain lymphoma 3 times higher than that of healthy brain tissue in mouse models of primary CNS lymphoma, whereas in mouse models of high-grade glial tumors, the binding level is very low, comparable to that of healthy tissue (background). Investigators hypothesize that [18F]-Fludarabine could be the radiopharmaceutical of choice for the diagnosis and monitoring of primary CNS lymphomas in PET.
The main objective of the study is to characterize the cerebral distribution and [18F]-Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET-MR imaging.
Detailed description
Monocenter, open, uncontrolled and non-randomized pilot study designed to evaluate the uptake of [18F]-Fludarabine in 16 patients with newly diagnosed CNS lymphoma at initial diagnosis, before treatment using hybrid PET/MR system.
Main objective: to characterize the brain distribution and tumoral uptake in CNS lymphoma before treatment. The secondary objectives are to compare PET-[18F]-Fludarabine results with those of morphological MRI with and without gadolinium injection, diffusion and perfusion MRI, proton-spectroscopy, histological or cytological diagnosis, and brain [18F]-FDG PET imaging.
Patient screening includes a clinical and neurological examination, diagnostic MRI, biological examination, [18F]-FDG PET examination to exclude systemic lymphoma, histological/cytological diagnosis of brain lymphoma. Once informed consent is obtained, one brain PET with [18F]-Fludarabine (4 MBq/kg) combined with simultaneous multiparametric MR sequences is scheduled.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-RMI | Experimental | Drug: PET-MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged ≥ 18 years
- Diagnosis of newly diagnosed high-grade CNS lymphoma (with histological and/or cytological confirmation)
- Patient naive to chemotherapy, or radiotherapy treatment for CNS lymphoma
- Contrast-enhanced intracranial mass greater than or equal to 1 cm longest axis
- Karnofsky index ≥ 40
Key exclusion criteria (17 listed)
- Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F]-Fludarabine
- Previous treatment for primary central nervous system lymphoma
- Isolated primary vitro-retinal lymphoma
- Isolated CNS relapse of a systemic lymphoma
- Other active cancer except basal cell carcinoma of the skin and/or cervical cancer in situ
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 |
|---|---|---|
| PET-MRI[18F]-Fludarabine imaging in the diagnostic workup of primary central nervous system lymphomas: a PET-MRI pilot study | Drug | PET-RMI |
Primary outcome
Measurements of [18F]-Fludarabine uptake in tumoral lesions and normal tissue using SUV, tumor/normal tissues ratios
Time frame: 15 days
Standardized measurement of [18F]-Fludarabine uptake (SUV) in tumor will be done on PET imaging superimposed on post gadolinium MRI.
7 secondary outcomes
Cerebral distribution of [18F]-Fludarabine in healthy and tumoral tissues
Time frame: 15 days
Temporal activity curves of [18F]-Fludarabine in healthy and tumoral tissues
Time frame: 15 days
Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG
Time frame: 15 days
Volumes of contrast enhancement in post-gadolinium T1-weighted MR sequence
Time frame: 15 days
Hypersignal in diffusion-weighted sequence and apparent diffusion coefficient (ADC)
Time frame: 15 days
Tumor perfusion, capillary permeability in perfusion weighted MRI
Time frame: 15 days
Metabolite ratios in spectroscopy
Time frame: 15 days
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 22 Aug 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Aurélie KAS, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PET-MRI in people with Primary Central Nervous System Lymphoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 17 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 22 Aug 2025. 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 France. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Measurements of [18F]-Fludarabine uptake in tumoral lesions and normal tissue using SUV, tumor/normal tissues ratios (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.