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

Who is this study for? Patients with Non-Hodgkin Lymphoma, Multiple Myeloma
What treatments are being studied? [68Ga]-Pentixafor
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Contact Information
Primary
Anton Nosov, MD
safonova@mskcc.org
212-639-8575
Backup
Heiko Schoder, MD
212-639-2079
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: Pentixapharm AG

This content was sourced from clinicaltrials.gov