Multiple Myeloma Clinical Trial
Official title:
In-human CXCR4 Imaging of Blood Cancers Using [68Ga]-Pentixafor-PET
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).
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | October 2025 |
| Est. primary completion date | October 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| 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 - 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center | Pentixapharm AG |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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