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In-human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET


Description

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).

Trial Eligibility

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)

Study Info

Organization

Memorial Sloan Kettering Cancer Center


Primary Outcome

Tumor standard uptake value (SUV)


Outcome Timeframe 1 year

NCTID NCT05093335

Phases EARLY_PHASE1

Primary Purpose DIAGNOSTIC

Start Date 2021-10-01

Completion Date 2025-10

Enrollment Target 30

Interventions

DRUG [68Ga]-Pentixafor

Locations Recruiting

Memorial Sloan Kettering Cancer Center

United States, New York, New York


Interested in joining this trial?

Our dedicated patient navigators are here to support you by reviewing the eligibility criteria to see if you might qualify for this trial.

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