In-Human CXCR4 Imaging of Blood Cancers Using [68Ga]-Pentixafor-PET

Study Overview
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Brief Summary
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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).

Official Title
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In-human CXCR4 Imaging of Blood Cancers Using [68Ga]-Pentixafor-PET

Conditions
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Non-Hodgkin Lymphoma, Multiple Myeloma, Histiocytic Neoplasms, Erdheim-Chester Disease, Rosai-Dorfman Disease

Intervention / Treatment
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* Drug: [68Ga]-Pentixafor


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This protocol is a pilot protocol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [68Ga]-Pentixafor<br>An intravenous bolus of 4.1 mCi (150 MBq) ± 10% of [68Ga]-Pentixafor will be injected in all participants that will be imaged on a hybrid PET/CT device. Any of the following factors may determine if imaging cannot be performed: tolerance/compliance in the PET/CT scanner; dose availability; dose quality control; availability of the PET/CT scanner or availability of study personnel. [68Ga]-Pentixafor uptake dynamics / pharmacokinetics will be evaluated by PET/CT performed with a low-dose CT component used for PET attenuation correction (1-2 mSv). [68Ga]-Pentixafor-PET/CT scan duration will be approximately 1.5 hours. Some patients will have two scans. | Drug: [68Ga]-Pentixafor<br>* An intravenous bolus of 4.1 mCi (150 MBq) ± 10% of [68Ga]-Pentixafor will be injected in all participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor standard uptake value (SUV) | Means and 95% confidence intervals for [68Ga]-Pentixafor standardized uptake values (SUV) and tumor-to-background ratios (TBR) of tumors will be recorded. Uptake will be measured in tumors. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[68Ga]-Pentixafor, PET/CT scan, In-human CXCR4 Imaging, 21-356, Symptomatic multiple myeloma, pre-cursor myeloma, MGUS, SMM, Memorial Sloan Kettering Cancer Center