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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-Pentixather
68Ga-Pentixafor
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring multiple myeloma, CXCR4, 68Ga-pentixather, PET/CT, 68Ga-pentixafor

Eligibility Criteria

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

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan

Arm Description

Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval

Outcomes

Primary Outcome Measures

Metabolic parameter
Comparison of metabolic parameter (SUVmax) between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
PET-positive diffuse bone marrow involvement
Comparison of the number of diffuse bone marrow involvement between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
PET-positive focal bone marrow lesions
Comparison of the number of focal bone marrow lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
PET-positive extramedullary lesions
Comparison of the number of extramedullary lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.

Secondary Outcome Measures

Adverse effects
Types of adverse events.
Tumor burden assessment
The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and clinical staging
Follow-up assessment
The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and follow-up parameter (PFS).
CXCR4 expression in biopsies and metabolic parameters in PET
The correlation between CXCR4 expression in biopsies and metabolic parameter (SUVmax) in PET.

Full Information

First Posted
November 10, 2021
Last Updated
May 3, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05364177
Brief Title
68Ga-pentixather and 68Ga-pentixafor PET/CT in Multiple Myeloma
Official Title
Comparison of 68Ga-pentixather and 68Ga-pentixafor PET/CT in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, CXCR4, 68Ga-pentixather, PET/CT, 68Ga-pentixafor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
68Ga-pentixather PET/CT, 68Ga-pentixafor PET/CT
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan
Arm Type
Experimental
Arm Description
Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval
Intervention Type
Drug
Intervention Name(s)
68Ga-Pentixather
Other Intervention Name(s)
68Ga-Pentixather injection
Intervention Description
After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed.
Intervention Type
Drug
Intervention Name(s)
68Ga-Pentixafor
Other Intervention Name(s)
68Ga-Pentixafor injection
Intervention Description
After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed.
Primary Outcome Measure Information:
Title
Metabolic parameter
Description
Comparison of metabolic parameter (SUVmax) between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
Time Frame
through study completion, an average of 2 years
Title
PET-positive diffuse bone marrow involvement
Description
Comparison of the number of diffuse bone marrow involvement between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
Time Frame
through study completion, an average of 2 years
Title
PET-positive focal bone marrow lesions
Description
Comparison of the number of focal bone marrow lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
Time Frame
through study completion, an average of 2 years
Title
PET-positive extramedullary lesions
Description
Comparison of the number of extramedullary lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Adverse effects
Description
Types of adverse events.
Time Frame
through study completion, an average of 2 years
Title
Tumor burden assessment
Description
The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and clinical staging
Time Frame
through study completion, an average of 2 years
Title
Follow-up assessment
Description
The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and follow-up parameter (PFS).
Time Frame
through study completion, an average of 2 years
Title
CXCR4 expression in biopsies and metabolic parameters in PET
Description
The correlation between CXCR4 expression in biopsies and metabolic parameter (SUVmax) in PET.
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected or confirmed untreated multiple myeloma (MM), relapsed MM, MM in remission Signed written consent Exclusion Criteria: pregnancy breastfeeding known allergy against pentixather or pentixafor any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huo, MD.
Phone
86-10-69155537
Email
huoli@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiao Yang, MD.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Huo, MD.
Phone
86-10-69155537
Email
huoli@pumch.cn

12. IPD Sharing Statement

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

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