Testing a new PET scan tracer that targets CXCR4 in advanced cancers
Tests a new PET imaging tracer in adults with advanced tumors or myeloma.
Plain-language title generated from the registry record
Registry title: Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.
Key facts
- Where
- Naples, ItalySee the site
- Phase
- Early phase 1
Where in Italy
- Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia MetabolicaNaples, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Institute, Naples
- Trial code
- NCT07577206EU 2024-513303-14-00
- Record updated
- 11 May 2026
- Original description
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.Read full original descriptionShow less
Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.
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.
Inclusion: Patients > 18 years; Patients with histological diagnosis of solid neoplasm (breast, lung, colon, ovary, pancreas) in advanced stages or multiple myeloma evaluated by PET/CT with [18F]FDG carried out in the 3 months prior to enrollment. The neoplasm must express the CXCR4 receptor by immunohistochemistry; Patients with ECOG performance status 0-2, able to undergo the scheduled diagnostic procedure (PET/CT with [68Ga]Ga-R54); Patients with alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase <3 x upper limit of reference range and total bilirubin <2.0 mg/dL; Patients with creatinine < 1.5 x upper limit of reference range or 24-hour creatinine clearance > 50 mL/min; Negative serum pregnancy test (b-hCG) for women of childbearing age before administration of [68Ga]Ga-R54); Signature of informed consent indicating that the patient (or legal representative) has been informed of all aspects pertinent to the study; Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures.
Exclusion: Presence of active infections (e.g. requiring antibiotic therapy) or other serious concomitant illness, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study; Recovery from major trauma including surgery within 4 weeks of study enrollment; Declared chronic active hepatitis (hepatitis B / C); Declared active autoimmune diseases; Presence of neurodegenerative diseases; Any conditions that in the opinion of the investigator could hinder compliance with the study protocol; Pregnancy and/or breastfeeding; Patients who have not signed consent to participate in the study.