RecruitingEarly Phase 1NCT07577206

Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.

Sponsor

National Cancer Institute, Naples

Enrollment

10 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Multiple Myeloma

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria8

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUG[68Ga]Ga-R54 PET/CT

A single intravenous microdose (≤100 μg) of the CXCR4-targeting radiopharmaceutical \[68Ga\]Ga-R54 is administered, followed by whole-body PET/CT imaging. Serial blood samples are collected up to 4 hours post-injection to assess pharmacokinetics. Imaging is performed according to institutional standards to evaluate in vivo CXCR4 expression in tumor lesions.