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Pivotal phase III registration clinical trial to evaluate the diagnostic capability and safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a positron emission tomography (PET) radiological agent, versus [18F]FDG PET/CT, for staging patients with confirmed marginal zone lymphoma as an example of CXCR4-positive malignant lymphomas: a prospective, international, multicentre, multicentre, comparative, randomised, cross-over, open-label lymphoma diagnostic trial (LYMFOR).
THE AIM IS TO EVALUATE WHETHER PET/CT SCANNING WITH [68GA]GA-PTF CAN IMPROVE DIAGNOSTIC ACCURACY COMPARED TO [18F]FDG IN PATIENTS WITH MZL, ALLOWING A MORE ACCURATE DETERMINATION OF THE EXTENT OF DISEASE.
Specialist
Nuclear Medicine Department
Navarre headquarters
Technical Summary
- PIVOTAL PHASE III REGISTRATION CLINICAL TRIAL TO EVALUATE THE DIAGNOSTIC CAPABILITY AND SAFETY OF [68GA]GA-PENTIXAFOR ([68GA]GA-PTF), A POSITRON EMISSION TOMOGRAPHY (PET) RADIOLOGICAL AGENT, VERSUS [18F]FDG PET/CT, FOR STAGING PATIENTS WITH CONFIRMED MARGINAL ZONE LYMPHOMA AS AN EXAMPLE OF CXCR4-POSITIVE MALIGNANT LYMPHOMAS: A PROSPECTIVE, INTERNATIONAL, MULTICENTRE, MULTICENTRE, COMPARATIVE, RANDOMISED, CROSS-OVER, OPEN-LABEL LYMPHOMA DIAGNOSTIC TRIAL (LYMFOR).
- Code EudraCT: 2022-500918-25
- Protocol number: PTF301
- Promoter: PentixaPharm GmbH
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