Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.
Recruiting
Early Phase 1Interventional Study
Advanced Solid TumorMultiple Myeloma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
10 (estimated)
Sponsor
National Cancer Institute, Naples · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility 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 …
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.