Clinical trial NCT05364177: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Multiple Myeloma
Keywords: multiple myeloma
CXCR4
68Ga-pentixather
PET/CT
68Ga-pentixafor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 68Ga-pentixather PET/CT, 68Ga-pentixafor PET/CT
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic parameter
timeFrame: through study completion, an average of 2 years
measure: PET-positive diffuse bone marrow involvement
timeFrame: through study completion, an average of 2 years
measure: PET-positive focal bone marrow lesions
timeFrame: through study completion, an average of 2 years
measure: PET-positive extramedullary lesions
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Adverse effects
timeFrame: through study completion, an average of 2 years
measure: Tumor burden assessment
timeFrame: through study completion, an average of 2 years
measure: Follow-up assessment
timeFrame: through study completion, an average of 2 years
measure: CXCR4 expression in biopsies and metabolic parameters in PET
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Qiao Yang, MD.
role: PRINCIPAL_INVESTIGATOR
References: