NCT05452005 Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
| NCT ID | NCT05452005 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, Davis |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-09-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates fluorine-18-AlphaVBeta6-BP (\[18F\]-αvβ6-BP) as a Positron Emission (PET) imaging agent in Non-Small Cell Lung Cancer (NSCLC) patients with brain metastases. Investigators hypothesize that \[18F\]-αvβ6-BP PET/Computed Tomography (CT) is a sensitive tool for disease assessment in patients with metastatic NSCLC, including those with brain metastases.
Eligibility Criteria
Inclusion Criteria: 1. Men and women age \>18 yrs 2. Biopsy proven NSCLC with brain metastases (treated or untreated) 3. Life-expectancy of ≥3 months in the opinion of the treating physician 4. Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available. 5. Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan 6. Ability to understand and willingness to sign a written informed consent document. 7. Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging 8. \[18F\]-FDG PET/CT within 21 days of enrollment 9. MRI brain within 21 days of enrollment 10. Eastern Cooperative Oncology Group Performance Status ≤ 2 11. Glomerular filtration rate (GFR) ≥ 60 Exclusion Criteria: 1. Pregnant or lactating women 2. Prisoners 3. Concurrent malignancy of a different histology that could confound imaging interpretation 4. Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
Contact & Investigator
Julie L. Sutcliffe, PhD
PRINCIPAL INVESTIGATOR
The Regents of the University of California (Davis)
Frequently Asked Questions
Who can join the NCT05452005 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05452005 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05452005 currently recruiting?
Yes, NCT05452005 is actively recruiting participants. Contact the research team at jlsutcliffe@ucdavis.edu for enrollment information.
Where is the NCT05452005 trial being conducted?
This trial is being conducted at Sacramento, United States.
Who is sponsoring the NCT05452005 clinical trial?
NCT05452005 is sponsored by University of California, Davis. The principal investigator is Julie L. Sutcliffe, PhD at The Regents of the University of California (Davis). The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.