NCT05093335EARLY_PHASE1Recruiting
In-Human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET
Memorial Sloan Kettering Cancer Center
Start Date
10/1/2021
Completion Date
10/1/2027
Summary
The purpose of this study is to determine the uptake of the imaging agent \[68Ga\]-pentixafor with PET/CT scans in people with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), and non-Hodgkin lymphoma (NHL), or you have histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
Twenty patients with histologically proven treatment-naïve, therapy-refractory or relapsed blood cancers meeting the below criteria will be included:
* Indolent B- or T-cell Non-Hodgkin lymphoma (including cutaneous lymphomas) or Non-Hodgkin lymphoma with variable FDG uptake and clinical course, such as mantle cell lymphoma; and measurable disease according to Lugano criteria
or
* Histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD)
* MGUS/SMM or MM according to IMWG definitions
* Solid tumors, such as lung cancers, meningioma, adrenocortical neoplasms including cortisol-producing adenomas or high suspicion for tumor, such as in patients with Cushing's disease.
* Age ≥18
* Negative serum pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards \& Guidelines) from assays obtained \<2 weeks prior to study enrollment/intervention; or negative urine pregnancy test performed on the day of intervention
* MSKCC patients
Exclusion Criteria:
* Breast-feeding
* History of renal functional disorders (chronic kidney disease with eGFR\<30)
* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
Interventions
DRUG
[68Ga]-Pentixafor
Conditions
Non-Hodgkin LymphomaMultiple MyelomaHistiocytic NeoplasmsErdheim-Chester DiseaseRosai-Dorfman Disease
Locations
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States