Single microdose [68Ga]Ga-R54 PET scan to image CXCR4 in advanced solid tumors and multiple myeloma
Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.
We will try a single microdose of the PET tracer [68Ga]Ga-R54 to see if it binds CXCR4 in people with advanced solid tumors or multiple myeloma.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples, Italia) |
| Trial ID | NCT07577206 on ClinicalTrials.gov |
What this trial studies
This is a monocentric, open-label microdose investigation of a new CXCR4-directed PET radiopharmaceutical, [68Ga]Ga-R54. Between 5 and 10 patients with advanced solid tumors or multiple myeloma whose tumors express CXCR4 will receive a single intravenous microdose (≤100 μg) and undergo PET/CT imaging to localize tracer uptake. Pharmacokinetics will be characterized by serial blood samples taken up to 4 hours after injection and patients will be enrolled at least seven days apart to monitor safety. The primary focus is on tracer biodistribution, target engagement, and early pharmacodynamic and safety signals.
Who should consider this trial
Good fit: Adults (≥18 years) with advanced breast, lung, colon, ovary, pancreas cancers or multiple myeloma whose tumors show CXCR4 by immunohistochemistry, with ECOG 0–2 and acceptable liver and kidney function are ideal candidates.
Not a fit: Patients without CXCR4 expression, pregnant individuals, those with organ dysfunction outside the entry criteria, or those with early-stage disease are unlikely to benefit from this microdose imaging approach.
Why it matters
Potential benefit: If successful, this tracer could help doctors locate CXCR4-expressing tumors and improve imaging to guide diagnosis and future treatment choices.
How similar studies have performed: Similar CXCR4-targeted PET tracers such as [68Ga]Pentixafor have been used successfully in clinical imaging, so the approach has precedent though [68Ga]Ga-R54 itself is a novel probe.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 * Declared chronic active hepatitis (hepatitis B / C) * Declared active autoimmune diseases * Recovery from major trauma including surgery within 4 weeks of study enrollment * Presence of neurodegenerative diseases * Pregnancy and/or breastfeeding * Any conditions that in the opinion of the investigator could hinder compliance with the study protocol * Patients who have not signed consent to participate in the study
Where this trial is running
Naples, Italia
- Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica — Naples, Italia, Italy (Recruiting)
Study contacts
- Principal investigator: Secondo Lastoria, M.D. — Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
- Study coordinator: Stefania Scala, M.D.
- Email: s.scala@istitutotumori.na.it
- Phone: 08117770596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.