Erdheim-Chester Disease, Histiocytic Neoplasms, Multiple Myeloma, Non-Hodgkin Lymphoma, Rosai-Dorfman Disease
Conditions
Keywords
[68Ga]-Pentixafor, PET/CT scan, In-human CXCR4 Imaging, 21-356, Symptomatic multiple myeloma, pre-cursor myeloma, MGUS, SMM, Memorial Sloan Kettering Cancer Center
Brief 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).
Interventions
DRUG[68Ga]-Pentixafor
An intravenous bolus of 3 -5 mCi of \[68Ga\]-Pentixafor will be injected in all participants.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This protocol is a pilot protocol.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor standard uptake value (SUV) | 1 year | 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. |
Countries
United States
Contacts
CONTACTAnton Nosov, MD
CONTACTHeiko Schoder, MD
PRINCIPAL_INVESTIGATORAnton Nosov, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed