[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma
NCT06125028 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2026-04-28
Summary
This will be a pivotal prospective prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial to assess the diagnostic performance and safety of the positron emission tomography (PET) imaging agent \[68Ga\]Ga-PTF) , versus \[18F\]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma exemplary for CXCR4-positive malignant lymphomas.
Conditions
Interventions
- DRUG
-
[68Ga]Ga-PentixaFor
\[68Ga\]Ga-PTF i.v. injection
- DRUG
-
[18F]Fluorodeoxyglucose
\[18F\]FDG i.v. injection.
Sponsors & Collaborators
-
Pivotal S.L.
collaborator INDUSTRY -
Pentixapharm AG
lead INDUSTRY
Principal Investigators
-
Andreas Buck, Prof. Dr. · University Hospital Würzburg, Department of Nuclear Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-20
- Primary Completion
- 2025-07-18
- Completion
- 2025-07-18
Countries
- Austria
- France
- Germany
- Italy
- Spain
Study Locations
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