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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Early Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: 68Ga-Pentixather; Drug: 68Ga-Pentixafor

Study type: Interventional

Funder types: Other

Identifiers

NCT05364177

PUMCH-MM-pentixather

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Drug: 68Ga-Pentixafor

Drug: 68Ga-Pentixather