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RECRUITING
NCT07577206
EARLY_PHASE1

Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.

Sponsor: National Cancer Institute, Naples

View on ClinicalTrials.gov

Summary

Phase 1, monocentric, open labeled, no profit "Microdose" trial. A single microdose of the new \[68Ga\]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-01-24

Completion Date

2027-01

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

DRUG

[68Ga]Ga-R54 PET/CT

A single intravenous microdose (≤100 μg) of the CXCR4-targeting radiopharmaceutical \[68Ga\]Ga-R54 is administered, followed by whole-body PET/CT imaging. Serial blood samples are collected up to 4 hours post-injection to assess pharmacokinetics. Imaging is performed according to institutional standards to evaluate in vivo CXCR4 expression in tumor lesions.

Locations (1)

Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica

Naples, Italia, Italy