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NCT05093335 | RECRUITING | Non-Hodgkin Lymphoma


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

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).

Condition or disease

Non-Hodgkin Lymphoma

Multiple Myeloma

Histiocytic Neoplasms

Erdheim-Chester Disease

Rosai-Dorfman Disease

Intervention/treatment

[68Ga]-Pentixafor

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : In-human CXCR4 Imaging of Hematologic and Solid Tumors Using [68Ga]-Pentixafor-PET
Actual Study Start Date : 2021-10-01
Estimated Primary Completion Date : 2026-10
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)

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

Location Details

NCT05093335


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Locations


RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

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