NCT07577206RecruitingEarly phase 1
Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 24 Jan 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- National Cancer Institute, Naples
- Diseases
- Multiple myeloma
- NCT number
- NCT07577206
- EU CT number
- 2024-513303-14-00
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 24 Jan 2025 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Pregnancy and/or breastfeeding
- Patients who have not signed consent to participate in the study
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.