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

Primary Purpose

Non-Hodgkin Lymphoma, Multiple Myeloma, Histiocytic Neoplasms

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

[68Ga]-Pentixafor

About this trial

This is an interventional diagnostic trial for Non-Hodgkin Lymphoma focused on measuring [68Ga]-Pentixafor, PET/CT scan, In-human CXCR4 Imaging, 21-356, Symptomatic multiple myeloma, pre-cursor myeloma, MGUS, SMM, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[68Ga]-Pentixafor

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05093335

First Posted

October 1, 2021

Last Updated

August 30, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

PentixaPharm GmbH

1. Study Identification

Unique Protocol Identification Number

NCT05093335

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

October 2025 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

PentixaPharm GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. 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), or you have histiocytic neoplasms (Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD) and/or Rosai-Dorfman disease (RDD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin Lymphoma, Multiple Myeloma, Histiocytic Neoplasms, Erdheim-Chester Disease, Rosai-Dorfman Disease

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

This protocol is a pilot protocol.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

[68Ga]-Pentixafor

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

[68Ga]-Pentixafor

Intervention Description

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

Primary Outcome Measure Information:

Title

Tumor standard uptake value (SUV)

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Simone Krebs, MD

Phone

212-639-7998

krebss@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Heiko Schoder, MD

Phone

212-639-2079

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simone Krebs, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Simone Krebs, MD

Phone

212-639-7998

First Name & Middle Initial & Last Name & Degree

Heiko Schoder, MD

Phone

212-639-2079

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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