Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)
Yusuf Menda
Summary
This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients who have been diagnosed with, and previously treated, for atypical carcinoid lesions of the lung.
Description
This is a study to determine what dose is acceptably safe for further testing. In this study, participants are asked to: * undergo SPECT/CT imaging with Lead-203 Pentixather (a radiotracer) to ensure the tumor lesions have the needed receptors * undergo serial blood sampling for during and after the SPECT/CT scan for radiation and dosimetry calculations (to determine how much of the Lead-212 Pentixather to administer) * receive up to 2 infusions of arginine \& lysine as a kidney protectant * receive up to 2 infusions of Lead-212 Pentixather, 6 weeks between each infusion * undergo imaging at…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * ability to provide independent consent * adequate bone marrow function (platelet count ≥ 100,000; hemoglobin of ≥ 10 g/dL; neutrophil count ≥ 1,500 cells/mm3) * adequate kidney function (creatinine clearance of ≥ 50 mL/min using the Cockcroft-Gault equation * adequate liver function (serum bilirubin ≤ 3x the upper limit of normal, AST ≤ 5x the upper limit of normal, and ALT ≤ 5x the upper limit of normal) * failed initial therapy or declined further therapy known to confer benefit * have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pe…
Interventions
- Drug212-Lead Pentixather
Pentixather radiolabeled with 212-lead to target malignant cells with the CXCR4 ligand.
- Diagnostic Test203-Lead Pentixather SPECT/CT
Pentixather radiolabeled with 203-Lead to identify the CXCR4 ligand on the malignant lesions for dosimetric analysis and treatment planning.
Location
- University of Iowa Health CareIowa City, Iowa