Last reviewed · How we verify
NCT05390814: FLUDALOC
[18F]-Fludarabine PET/MRI in Primary Central Nervous System Lymphoma
Phase 1 trial testing PET-MRI in Primary Central Nervous System Lymphoma in 10 participants. Completed in 5 December 2024.
5 December 2024
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 10 |
| Start date | 18 December 2023 |
| Primary completion | 5 December 2024 |
| Estimated completion | 5 December 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- PET-MRI — full drug profile →
Conditions studied
- Primary Central Nervous System Lymphoma — all drugs for Primary Central Nervous System Lymphoma →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Primary Central Nervous System Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Recent Updates of PET in Lymphoma: FDG and Beyond.
Kim SY, Chung HW, So Y, Lee MH, et al · · 2024 · cited 2× · PMID 39595051 · DOI 10.3390/biomedicines12112485
Verify or expand the search:
- PubMed search for NCT05390814
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Primary Central Nervous System Lymphoma
Currently open trials in the same condition.
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- NCT06475235 — Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL · Phase 1 · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05390814 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 22 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05390814.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing