Menu
Recruiting NCT05093335

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

Early Phase I Interventional Non-Hodgkin Lymphoma Multiple Myeloma Histiocytic Neoplasms Erdheim-Chester Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [68Ga]-Pentixafor.
Who it may be relevant to
Registry conditions: Non-Hodgkin Lymphoma, Multiple Myeloma, Histiocytic Neoplasms, Erdheim-Chester Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Tumor standard uptake value (SUV) [Time frame: 1 year]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Memorial Sloan Kettering Cancer Center — New York

Identifiers

NCT: NCT05093335 · 21-356

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗