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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]-Pentixafor | Experimental | An intravenous bolus of 3 -5 mCi [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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]-Pentixafor | Drug | An intravenous bolus of 3 -5 mCi of [68Ga]-Pentixafor will be injected in all participants. |
|
| 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 |
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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:
or
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anton Nosov, MD | Contact | 212-639-8575 | nosova@mskcc.org | |
| Heiko Schoder, MD | Contact | 212-639-2079 |
| Name | Affiliation | Role |
|---|---|---|
| Anton Nosov, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D031249 | Erdheim-Chester Disease |
| D015618 | Histiocytosis, Sinus |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000597686 | 68Ga-pentixafor |
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This protocol is a pilot protocol.
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D015616 | Histiocytosis, Non-Langerhans-Cell |
| D015614 | Histiocytosis |