In-Human CXCR4 Imaging of Blood Cancers Using [68Ga]-Pentixafor-PET

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05093335

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma Multiple Myeloma	Drug: [68Ga]-Pentixafor	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This protocol is a pilot protocol.This protocol is a pilot protocol.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

In-human CXCR4 Imaging of Blood Cancers Using [68Ga]-Pentixafor-PET

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [68Ga]-Pentixafor An intravenous bolus of 4.1 mCi (150 MBq) ± 10% of [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.	Drug: [68Ga]-Pentixafor An intravenous bolus of 4.1 mCi (150 MBq) ± 10% of [68Ga]-Pentixafor will be injected in all participants.

Arm

Intervention/Treatment

Experimental: [68Ga]-Pentixafor

An intravenous bolus of 4.1 mCi (150 MBq) ± 10% of [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.

Drug: [68Ga]-Pentixafor

An intravenous bolus of 4.1 mCi (150 MBq) ± 10% of [68Ga]-Pentixafor will be injected in all participants.

Outcome Measures

Primary Outcome Measures

Tumor standard uptake value (SUV) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
MGUS/SMM or MM according to IMWG definitions
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)