Actively Recruiting
Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.
Led by National Cancer Institute, Naples · Updated on 2026-05-11
10
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Histological diagnosis of advanced solid tumors (breast, lung, colon, ovary, pancreas) or multiple myeloma
- Neoplasm must express the CXCR4 receptor confirmed by immunohistochemistry
- ECOG performance status between 0 and 2
- Alkaline phosphatase, ALT, and AST levels less than 3 times the upper limit of normal; total bilirubin less than 2.0 mg/dL
- Creatinine less than 1.5 times upper limit of normal or 24-hour creatinine clearance above 50 mL/min
- Negative serum pregnancy test for women of childbearing potential before drug administration
- Signed informed consent
- Willingness and ability to comply with study visits and procedures
You will not qualify if you...
- Active infections requiring antibiotic therapy or other serious illnesses
- Chronic active hepatitis B or C
- Active autoimmune diseases
- Major trauma or surgery within 4 weeks before enrollment
- Presence of neurodegenerative diseases
- Pregnancy or breastfeeding
- Conditions that may interfere with adherence to the study protocol
- Lack of signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica
Naples, Italia, Italy, 80131
Actively Recruiting
Research Team
S
Stefania Scala, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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