Brain Metastases, Lung Cancer, Lung Cancer Metastatic, Non Small Cell Lung Cancer
Conditions
Keywords
Positron Emission Tomography
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.
Detailed description
PRIMARY OBJECTIVE: The primary objective of this study is to evaluate the sensitivity and specificity of \[18F\]-αvβ6-BP PET/CT for detecting metastases in patients with NSCLC. OUTLINE: Patients will undergo \[18F\]-αvβ6-BP PET/CT at baseline in addition to standard-of-care \[18F\]-2-fluoro-2-deoxy-D-glucose (FDG) PET/CT body and magnetic resonance imaging (MRI) of the brain. Patients will then undergo standard-of-care cancer directed therapy. Patients will be re-staged 8-12 weeks later at the next standard-of-care imaging time point with \[18F\]-αvβ6-BP PET/CT, \[18F\]-FDG PET/CT, and MRI.
Interventions
DRUG[18F]-αvβ6-BP
Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.
Sponsors
University of California, Davis
United States Department of Defense
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry | Up to six months | Standard uptake value (SUV) values from \[18F\]-αvβ6-BP PET/CT will be compared to immunohistochemistry (IHC) αvβ6 staining of archival tissue to assess the sensitivity of \[18F\]-αvβ6-BP PET/CT to detect αvβ6 positive metastasis in NSCLC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging | Up to six months | Detection of lesions with \[18F\]-αvβ6-BP will be compared to the number of lesions identified during standard-of-care MRI imaging |
| Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging | Up to six months | SUVmax values obtained during standard-of-care FDG/PET will be compared to SUVmax values obtained from \[18F\]-αvβ6-BP PET/CT imaging |
| Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment | Up to six months | Lesion response will be assessed based on standard-of-care MRI images, \[18F\]-FDG PET/CT and \[18F\]-αvβ6-BP PET/CT post treatment. |
Countries
United States
Contacts
CONTACTPrincipal Investigator
CONTACTJulie L Sutcliffe
PRINCIPAL_INVESTIGATORJulie L. Sutcliffe, PhD
The Regents of the University of California (Davis)
Outcome results
None listed