RecruitingEarly Phase 1NCT05093335

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

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

30 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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 Criteria3

  • 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)

Interventions

DRUG[68Ga]-Pentixafor

An intravenous bolus of 3 -5 mCi of \[68Ga\]-Pentixafor will be injected in all participants.


Locations(1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT05093335


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