Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F]-αvβ6-BP.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
Overview
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.
Primary outcome measures
- [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry [Time frame: Up to six months]
Secondary outcome measures (3)
- Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging [Time frame: Up to six months]
- Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging [Time frame: Up to six months]
- Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment [Time frame: Up to six months]
Eligibility criteria
Inclusion criteria
- Men and women age >18 yrs
- Biopsy proven NSCLC with brain metastases (treated or untreated)
- Life-expectancy of ≥3 months in the opinion of the treating physician
- Available archival tumor tissue (excisional, core, or fine needle aspiration (FNA) is acceptable). Tissue from a metastatic site is preferred when available.
- Able to tolerate all study procedures, including remain motionless for up to 30-60 minutes per scan
- Ability to understand and willingness to sign a written informed consent document.
- Planned to undergo additional cancer-directed therapy followed by standard-of-care re-staging imaging
- \[18F\]-FDG PET/CT within 21 days of enrollment
- MRI brain within 21 days of enrollment
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- Glomerular filtration rate (GFR) ≥ 60
Exclusion criteria
- Pregnant or lactating women
- Prisoners
- Concurrent malignancy of a different histology that could confound imaging interpretation
- Patients who cannot undergo PET/CT scanning because of weight limits(>350lbs)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- The University of California Davis Comprehensive Cancer Center — Sacramento
Identifiers
NCT: NCT05452005 · 1718953