68Ga-pentixather and 68Ga-pentixafor PET/CT in Multiple Myeloma

May 3, 2022 updated by: Peking Union Medical College Hospital

Comparison of 68Ga-pentixather and 68Ga-pentixafor PET/CT in Patients With Multiple Myeloma

Chemokine receptor-4 (CXCR4) is overexpressed in multiple myeloma (MM) cells. 68Ga-pentixafor is a radio-labled tracer for CXCR4 . 68Ga-pentixafor PET/CT has shown good diagnostic performance in MM. But an exchange of Ga3+ by Lu3+ or Y3+ will lead to a significant loss of CXCR4 affinity. Investigators conduct this prospective study to evaluate the diagnostic performance of 68Ga-pentixather compared with 68Ga-pentixafor, in order to parallel 68Ga-pentixather and 177Lu/90Y-pentixather in theranostics of MM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple myeloma (MM) is a malignant plasma cell disorder which is characterized by clonal proliferation of plasma cell in bone marrow microenvironment. Chemokine receptor-4 (CXCR4) is overexpressed in MM cells, and has been identified as a potential therapy target. 68Ga-pentixafor is a radiolabeled ligand with high affinity for CXCR4. 68Ga-pentixafor PET/CT has been reported with better diagnostic performance than 18F-FDG PET/CT. However, considering both diagnostic and therapeutic applications, an exchange of Ga3+ by other M3+ ions (Lu or Y) will lead to a significant loss of CXCR4 affinity. Thus, pentixather was developed as the precursor of 177Lu-pentixather or 90Y-pentixather, which can be used in CXCR4-targeted peptide receptor radionuclide therapy (PRRT). Investigators conduct this prospective study to evaluate the diagnostic performance of 68Ga-pentixather compared with 68Ga-pentixafor, in order to parallel 68Ga-pentixather and 177Lu/90Y-pentixather in theranostics of MM.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Li Huo, MD.
  • Phone Number: 86-10-69155537
  • Email: huoli@pumch.cn

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Suspected or confirmed untreated multiple myeloma (MM), relapsed MM, MM in remission
  2. Signed written consent

Exclusion Criteria:

  1. pregnancy
  2. breastfeeding
  3. known allergy against pentixather or pentixafor
  4. any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan
Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval
Drug: 68Ga-Pentixather
After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed.
Other Names:
  • 68Ga-Pentixather injection
Drug: 68Ga-Pentixafor
After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed.
Other Names:
  • 68Ga-Pentixafor injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic parameter
Time Frame: through study completion, an average of 2 years
Comparison of metabolic parameter (SUVmax) between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
through study completion, an average of 2 years
PET-positive diffuse bone marrow involvement
Time Frame: through study completion, an average of 2 years
Comparison of the number of diffuse bone marrow involvement between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
through study completion, an average of 2 years
PET-positive focal bone marrow lesions
Time Frame: through study completion, an average of 2 years
Comparison of the number of focal bone marrow lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
through study completion, an average of 2 years
PET-positive extramedullary lesions
Time Frame: through study completion, an average of 2 years
Comparison of the number of extramedullary lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: through study completion, an average of 2 years
Types of adverse events.
through study completion, an average of 2 years
Tumor burden assessment
Time Frame: through study completion, an average of 2 years
The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and clinical staging
through study completion, an average of 2 years
Follow-up assessment
Time Frame: through study completion, an average of 2 years
The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and follow-up parameter (PFS).
through study completion, an average of 2 years
CXCR4 expression in biopsies and metabolic parameters in PET
Time Frame: through study completion, an average of 2 years
The correlation between CXCR4 expression in biopsies and metabolic parameter (SUVmax) in PET.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Qiao Yang, MD., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2021

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-MM-pentixather

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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