Using a new imaging agent to detect lung cancer spread
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
This study is testing a new imaging method to see if it can better detect the spread of lung cancer, especially to the brain, in patients with Non-Small Cell Lung Cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT05452005 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of fluorine-18-AlphaVBeta6-BP PET/CT imaging in detecting metastases in patients with Non-Small Cell Lung Cancer (NSCLC), particularly those with brain metastases. Participants will undergo this imaging technique alongside standard imaging methods to assess its sensitivity and specificity. The study aims to improve disease assessment and potentially enhance treatment planning for patients with metastatic NSCLC. Patients will be re-staged after 8-12 weeks to monitor changes in their condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with biopsy-proven NSCLC and brain metastases who are expected to undergo additional cancer-directed therapy.
Not a fit: Patients who are pregnant, lactating, or have concurrent malignancies of different histology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate imaging tool for assessing metastatic lung cancer, leading to better treatment decisions.
How similar studies have performed: While similar imaging approaches have been explored, the specific use of fluorine-18-AlphaVBeta6-BP PET/CT in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Sacramento, California
- The University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Julie L. Sutcliffe, PhD — The Regents of the University of California (Davis)
- Study coordinator: Principal Investigator
- Email: jlsutcliffe@ucdavis.edu
- Phone: 916-734-5536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.