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

NCT ID: NCT05364177

Last Updated: 2022-05-06

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

2021-08-11

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

68Ga-pentixather PET/CT, 68Ga-pentixafor PET/CT
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

68Ga-Pentixather

Intervention Type DRUG

After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed.

68Ga-Pentixafor

Intervention Type DRUG

After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed.

Interventions

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68Ga-Pentixather

After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed.

Intervention Type DRUG

68Ga-Pentixafor

After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed.

Intervention Type DRUG

Other Intervention Names

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68Ga-Pentixather injection 68Ga-Pentixafor injection

Eligibility Criteria

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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.
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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Qiao Yang, MD.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Huo, MD.

Role: CONTACT

86-10-69155537

Facility Contacts

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Li Huo, MD.

Role: primary

86-10-69155537

Other Identifiers

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PUMCH-MM-pentixather

Identifier Type: -

Identifier Source: org_study_id

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