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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

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.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • [68Ga]-Pentixafor

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: [68Ga]-PentixaforExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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