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[68Ga]Ga-PentixaFor vs [18F]FDG PET/CT for Staging Marginal Zone Lymphoma
NCT06125028Phase 3
Key facts
- Status
- Terminated
- Start
- May 2024
- Primary completion
- Jul 2025
- Countries
- 5
- Sponsor
- Pentixapharm
- Modality
- Peptides, Small Molecules
- Drugs
- pentixafor
- Conditions
- marginal zone lymphoma (MZL)
01
Overview
Phase 3, randomised, open-label trial of pentixafor in marginal zone lymphoma (MZL) (2 arms), sponsored by Pentixapharm. Primary endpoints: Sensitivity in tumor detection at 6 months and Specificity in tumor detection at 6 months. Started May 2024; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
[68Ga]Ga-PTF PET/CT
150 (+/-50) MBq [68Ga]Ga-PTF administered intravenously followed by PET/CT
[18F]FDG PET/CT
[18F]FDG administered intravenously followed by PET/CT
03
Who it enrols
Adult patients with histologically proven, treatment-naive marginal zone lymphoma, acceptable organ function, and life expectancy >= 12 weeks.
04
Endpoints
Primary
Sensitivity in tumor detection
Specificity in tumor detection
Secondary
Proportion of patients with a change in intended patient management
Positive predictive value
Negative predictive value
Adverse Events
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