A Safety Study of 212Pb-Pentixather Radioligand Therapy
Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 Pentixather SPECT/CT Exclusion Criteria: * major surgery within 4 weeks of consent * antoher investigational agent within 4 weeks of consent * uncontrolled illness including, but not limited to, ongoing or active infection that would necessitate a delay in therapy or cause a hospital admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hepatic cirrhosis or severe impairment, or psychiatric illness/social situations that would limit compliance with study requirements. * prior solid organ transplant * cytotoxic or antineoplastic therapy within 21 days of consent (42 days for nitrosoureas) * antibody therapy within the 21 days of consent * allogenic bone marrow or stem cell transplant, or any stem cell infusion, within 84 days of consent * pregnancy * breastfeeding * refusal to comply with birth control requirements during study
Study sites (1)
IA
- University of Iowa Health Care · Iowa City, IA 52242Yusuf Menda, MD · Study contact · 319-356-3214 · yusuf-menda@uiowa.eduKristin West, RN, BSN · Study contact · kristin-gaimari-varner@uiowa.eduYusuf Menda, MD · Principal investigatorStephen Graves, PhD · Sub-investigatorMore trials in Iowa City