[18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

18 Dec 2023 → 5 Dec 2024

Decision date (initial)

2024-11-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Greater Paris University Hospitals

External identifiers

EU CT number

2024-512758-62-00

EudraCT number

2021-005193-26

ClinicalTrials.gov

NCT05390814

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic

Characterize the cerebral distribution and [18F]-Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET-MR imaging.

Secondary objectives 1

1. Descriptively compare the results of [18F]-Fludarabine PET with : - morphological MRI with and without Gadolinium injection ; - the results of multiparametric MRI (diffusion, perfusion and spectroscopy) acquired with PET-MRI; - the results of histological or cytological diagnosis - the results of [18F]-FDG PET-CT (anatomical location and intensity of pathological foci, tumor/healthy tissue contrast).

Conditions and MedDRA coding

Patients with newly diagnosed primary central nervous system lymphoma naïve to surgery, radiotherapy or chemotherapy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Patients aged ≥ 18 years
2. Diagnosis of newly diagnosed high-grade CNS lymphoma (with histological and/or cytological confirmation)
3. Patient naive to chemotherapy, or radiotherapy treatment for CNS lymphoma
4. Contrast-enhanced intracranial mass greater than or equal to 1 cm longest axis
5. Karnofsky index ≥ 40
6. No systemic lymphoma on [18F]-FDG PET/CT
7. Creatinine clearance ≥ 30 mL/min
8. Social security affiliation (excluding AME)
9. 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

Exclusion criteria 17

1. Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F]-Fludarabine
2. Traitement antérieur pour un lymphome primitif du système nerveux central
3. Isolated primary vitro-retinal lymphoma
4. Isolated CNS relapse of a systemic lymphoma
5. Other active cancer except basal cell carcinoma of the skin and/or cervical cancer in situ
6. Immunosuppression (organ transplant in particular)
7. Treatment with dipyridamole
8. Positive HIV serology
9. Presence of another progressive pathology that is life-threatening in the short term
10. History of allergy to gadolinium chelates (DOTAREM®)
11. Absolute contraindication to MRI (pacemaker, cochlear implant ...), to the administration of gadolinium
12. Patient of childbearing potential without effective contraception, breastfeeding or pregnant
13. Severe cognitive impairment incompatible with good cooperation in the PET-MRI examination
14. Patient with pain or restlessness unable to remain motionless in supine position for 60 minutes
15. Weight > 100 Kg
16. Patient deprived of liberty or under legal protection (guardianship or curatorship)
17. Ongoing participation in another interventional research protocol. Participation in research of a non-interventional type is authorized

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Standardized measurement of tumor uptake of [18F]-Fludarabine (Standard uptake value or SUV) in tumor lesions, relative to SUV of healthy tissue quantified on PET images superimposed on MRI.

Secondary endpoints 8

1. Cerebral distribution and activity-time curves for [18F]-Fludarabine
2. Tumor/healthy tissue contrast on PET-[18F]-Fludarabine
3. Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG
4. lesion volumes in 3D T1 MRI with Gadolinium
5. Apparent diffusion coefficient (ADC) in diffusion MRI
6. Tumor perfusion in perfusion MRI
7. Metabolite ratios in spectroscopy
8. histological or cytological diagnosis

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Aurélie KAS

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Aurélie KAS

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications