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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.
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
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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