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

NCT ID: NCT03436342

Last Updated: 2019-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-Pentixafor, PET/CT

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

Group Type EXPERIMENTAL

68Ga-Pentixafor

Intervention Type DRUG

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.

Interventions

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68Ga-Pentixafor

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fang Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Li, M.D.

Role: CONTACT

Phone: 86-10-69155502

Email: [email protected]

Yaping Luo, M.D.

Role: CONTACT

Phone: 86-10-69157033

Email: [email protected]

Facility Contacts

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Fang Li, MD

Role: primary

Zhaohui Zhu, MD

Role: backup

References

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Pan Q, Chen Z, Liu S, Zhang H, Feng J, Miao W, Li F, Cao X, Luo Y. Reduced splenic uptake of [68Ga]Ga-Pentixafor following first-line chemotherapy is associated with poor prognosis in patients with newly diagnosed multiple myeloma. EJNMMI Res. 2025 Jun 20;15(1):74. doi: 10.1186/s13550-025-01262-2.

Reference Type DERIVED
PMID: 40540129 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31776631 (View on PubMed)

Other Identifiers

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PekingUMCHCXCR4

Identifier Type: -

Identifier Source: org_study_id