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Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma

Primary Purpose

Multiple Myeloma, Lymphoma

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
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

Eligibility Criteria

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

Inclusion criteria:

  • suspected or confirmed untreated MM or lymphoma patients
  • 18F-FDG PET/CT within two weeks
  • signed written consent.

Exclusion criteria:

  • pregnancy
  • breastfeeding
  • known allergy against Pentixafor
  • any medical condition that in the opinion of the investigator,may significantly interfere with study compliance.

Sites / Locations

  • Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-Pentixafor, PET/CT

Arm Description

Inject 68Ga-Pentixafor and then perform PET/CT scan.

Outcomes

Primary Outcome Measures

SUVmax
SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the L3 vertebra is defined as the general marrow activity on the condition that there is no focally hypermetabolic disease.

Secondary Outcome Measures

Diagnostic value
Diagnostic value of 68Ga-Pentixafor PET/CT for MM and lymphoma in comparison with 18F-FDG PET/CT.
Incidence of emergency events during the study
Incidence of emergency events during the study
Tumor burden assessement
Correlation between tumor burden assessed on 68Ga-Pentixafor PET/CT and the DS and ISS clinical staging system for MM.
Diagnostic value in special type of multiple myeloma
Diagnostic value of 68Ga-Pentixafor PET/CT in monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM) from symptomatic MM.
CXCR4 expression and SUV
Correlation between CXCR4 expression and SUV in PET
Overall Survival
analysis of OS for patients receiving 68Ga-Pentixafor PET/CT
Disease Free Survival
analysis of DFS for patients receiving 68Ga-Pentixafor PET/CT
Disease Specific Survival
analysis of DSS for patients receiving 68Ga-Pentixafor PET/CT

Full Information

First Posted
October 25, 2017
Last Updated
December 26, 2019
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03436342
Brief Title
Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma
Official Title
Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (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 CXCR4 was expressed in MM and lymphoma cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM and lymphoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM and lymphoma.
Detailed Description
Multiple myeloma: Multiple myeloma (MM) is characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. The Durie and Salmon and ISS clinical staging system have been well-accepted as a practical way to evaluate MM tumor burden nowadays. But it is difficult to assess the accurate tumor involvement because of the significant heterogeneity characterizing this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome. New imaging modalities such as 18F-FDG PET/CT has been used to improve the efficacy of this system in assessing the extent and severity of MM, but the diagnostic accuracy of 18F-FDG PET/CT decreased in lower proliferative MM cells and inflammation. Recent studies showed Chemokine receptor CXCR4 was expressed in MM cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM. Lymphoma: Lymphoma is a frequent cancer with high CXCR4 expression. According to the previous studies, 68Ga-pentixafor-PET seems to be a highly selective and specific method for the in vivo quantification of CXCR4 expression. Thus our study is going to investigate the value of 68Ga-pentixafor-PET/CT for the diagnosis,differentiation and pretherapeutic evaluation of CXCR4 expression in lymphoma.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-Pentixafor, PET/CT
Arm Type
Experimental
Arm Description
Inject 68Ga-Pentixafor and then perform PET/CT scan.
Intervention Type
Drug
Intervention Name(s)
68Ga-Pentixafor
Intervention Description
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga-Pentixafor will be used to image lesions of MM and lymphoma by PET/CT.
Primary Outcome Measure Information:
Title
SUVmax
Description
SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the L3 vertebra is defined as the general marrow activity on the condition that there is no focally hypermetabolic disease.
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Diagnostic value
Description
Diagnostic value of 68Ga-Pentixafor PET/CT for MM and lymphoma in comparison with 18F-FDG PET/CT.
Time Frame
through study completion, an average of 2 years
Title
Incidence of emergency events during the study
Description
Incidence of emergency events during the study
Time Frame
through study completion, an average of 2 years
Title
Tumor burden assessement
Description
Correlation between tumor burden assessed on 68Ga-Pentixafor PET/CT and the DS and ISS clinical staging system for MM.
Time Frame
through study completion, an average of 2 years
Title
Diagnostic value in special type of multiple myeloma
Description
Diagnostic value of 68Ga-Pentixafor PET/CT in monoclonal gammopathy of unknown significance (MGUS) and smoldering multiple myeloma (SMM) from symptomatic MM.
Time Frame
through study completion, an average of 2 years
Title
CXCR4 expression and SUV
Description
Correlation between CXCR4 expression and SUV in PET
Time Frame
through study completion, an average of 2 years
Title
Overall Survival
Description
analysis of OS for patients receiving 68Ga-Pentixafor PET/CT
Time Frame
1 year and 5 years after been diagnosed
Title
Disease Free Survival
Description
analysis of DFS for patients receiving 68Ga-Pentixafor PET/CT
Time Frame
1 year and 5 years after been diagnosed
Title
Disease Specific Survival
Description
analysis of DSS for patients receiving 68Ga-Pentixafor PET/CT
Time Frame
1 year and 5 years after been diagnosed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: suspected or confirmed untreated MM or lymphoma patients 18F-FDG PET/CT within two weeks signed written consent. Exclusion criteria: pregnancy breastfeeding known allergy against 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
Fang Li, M.D.
Phone
86-10-69155502
Email
lifang@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Luo, M.D.
Phone
86-10-69157033
Email
luoyaping@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Li, MD
Phone
86-10-69155502
Email
lifang@pumch.cn
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Phone
86-10-69154196
Email
zhuzhh@pumch.cn
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31776631
Citation
Pan Q, Cao X, Luo Y, Li J, Feng J, Li F. Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):537-546. doi: 10.1007/s00259-019-04605-z. Epub 2019 Nov 27.
Results Reference
derived

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Chemokine Receptor CXCR4-targeting Molecular Imaging for Metabolic Characterization of Multiple Myeloma and Lymphoma

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