Recruiting
Early Phase 1

CXCR4 Imaging

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05093335

Conditions

Non-Hodgkin Lymphoma

Multiple Myeloma

Histiocytic Neoplasms

Erdheim-Chester Disease

Rosai-Dorfman Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[68Ga]-Pentixafor

Study Details

Brief 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).

Conditions

Non-Hodgkin Lymphoma

Multiple Myeloma

Histiocytic Neoplasms

Erdheim-Chester Disease

Rosai-Dorfman Disease

Study ID

NCT05093335

Start date

Oct 1, 2021

Status verified date

Feb, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [68Ga]-Pentixafor

An intravenous bolus of 3 -5 mCi \[68Ga\]-Pentixafor will be injected in all participants that will be imaged on a hybrid PET/CT device. Any of the following factors may determine if imaging cannot be performed: tolerance/compliance in the PET/CT scanner; dose availability; dose quality control; availability of the PET/CT scanner or availability of study personnel. \[68Ga\]-Pentixafor uptake dynamics / pharmacokinetics will be evaluated by PET/CT performed with a low-dose CT component used for PET attenuation correction (1-2 mSv). \[68Ga\]-Pentixafor-PET/CT scan duration will be approximately 1.5 hours. Some patients will have two scans.

Interventions

[68Ga]-Pentixafor

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Anton Nosov, MD

212-639-8575nosova@mskcc.org

Heiko Schoder, MD

212-639-2079

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Anton Nosov, MD

212-639-8575

Heiko Schoder, MD

212-639-2079

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • [68Ga]-Pentixafor
  • PET/CT scan
  • In-human CXCR4 Imaging
  • 21-356
  • Symptomatic multiple myeloma
  • pre-cursor myeloma
  • MGUS
  • SMM
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-02-05.