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NCT Number: NCT05093335

In-Human CXCR4 Imaging of Hematologic and Solid Tumors 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).

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

[68Ga]-Pentixafor

Drug

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

Primary outcomes

  1. Tumor standard uptake value (SUV)

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anton Nosov, MD

CONTACT

[email protected]

212-639-8575

Heiko Schoder, MD

CONTACT

212-639-2079

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2021
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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