Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
NCT ID: NCT05452005
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2022-09-13
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Experimental [18F]-αvβ6-BP
Patients receive \[18F\]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.
[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.
Interventions
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[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.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of California, Davis
OTHER
Responsible Party
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Julie L. Sutcliffe, Ph.D
Professor of Internal Medicine and Biomedical Engineering
Principal Investigators
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Julie L. Sutcliffe, PhD
Role: PRINCIPAL_INVESTIGATOR
The Regents of the University of California (Davis)
Locations
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The University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Julie L Sutcliffe
Role: primary
Other Identifiers
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1718953
Identifier Type: -
Identifier Source: org_study_id