Single microdose [68Ga]Ga-R54 PET scan to image CXCR4 in advanced solid tumors and multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.