This early phase I trial evaluates the uptake of the imaging agent [68Ga]-pentixafor in patients with blood cancer or solid tumors who are undergoing positron emission tomography (PET)/computed tomography (CT). The uptake of [68Ga]-pentixafor is the amount of absorption of the agent into tissues and cells. A PET/CT scan shows how tissues and organs are functioning. [68Ga]-pentixafor is a radioactive tracer that is given through a vein, and it gives off a small amount of radioactivity as it travels throughout the body. The radioactivity builds up in the locations where disease is, and it can help PET/CT scans see and take pictures of the disease. This trial aims to see whether [68Ga]-pentixafor works better than standard of care fluorodeoxyglucose ([18F]-FDG) in detecting and providing information about blood cancers and solid tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05093335.
PRIMARY OBJECTIVE:
I. To obtain gallium Ga 68 pentixafor ([68Ga]-Pentixafor) biodistribution data in hematologic and solid tumor patients to establish a solid base for future experiments.
SECONDARY OBJECTIVES:
I. To determine whether [68Ga]-Pentixafor uptake differs between different blood cancers (e.g. different lymphoma subtypes) and solid tumors, and between involved versus (vs.) uninvolved bone marrow according to biopsy/histology.
II. To determine, by means of post-treatment [68Ga]-Pentixafor-PET performed in a subset of patients, possible effects of therapies on tracer biodistribution.
III. To perform safety monitoring using standard serious adverse event (SAE) reporting.
OUTLINE:
Patients receive gallium Ga 68 pentixafor intravenously (IV) and simultaneously undergo PET over 30 minutes. Starting 30-60 minutes post injection, patients undergo PET/CT or PET/magnetic resonance imaging (MRI) over 30 minutes. Some patients may receive gallium Ga 68 pentixafor and undergo PET/CT or PET/MRI scans twice, once before and once after standard of care treatment.
One day after completion of study intervention, patients receive a follow up phone call.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAnton Nosov
