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

Last updated: January 21, 2026
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Not Recruiting

Phase

1

Condition

Hematologic Neoplasms

Red Blood Cell Disorders

Bone Neoplasm

Treatment

[68Ga]-Pentixafor

Clinical Study ID

NCT05093335
21-356
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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) orNon-Hodgkin lymphoma with variable FDG uptake and clinical course, such as mantlecell 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 includingcortisol-producing adenomas or high suspicion for tumor, such as in patients withCushing's disease.

  • Age ≥18

  • Negative serum pregnancy test for female volunteers of childbearing age andpotential (as defined by MSKCC Standards & Guidelines) from assays obtained <2 weeksprior to study enrollment/intervention; or negative urine pregnancy test performedon the day of intervention

  • MSKCC patients

Exclusion

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 toclaustrophobia)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: [68Ga]-Pentixafor
Phase: 1
Study Start date:
October 01, 2021
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

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