NCT05557708Not yet recruitingEarly phase 1
A Safety Study of 212Pb-Pentixather Radioligand Therapy
Biodistribution of 68Ga Pentixafor in Patients With Small Cell Lung Carcinoma (SCLC)
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 20 Sept 2022
- Start date
- 1 Jul 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Yusuf Menda
- Diseases
- Neuroendocrine tumours, Lung cancer
- NCT number
- NCT05557708
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 1 Jul 2026 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- major surgery within 4 weeks of consent
- antoher investigational agent within 4 weeks of consent
- 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
Other illness
- 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.
Other
- pregnancy
- breastfeeding
- refusal to comply with birth control requirements during study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Health Care Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.