Clinical trial NCT05452005: Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
Official title: Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lung Cancer
Lung Cancer Metastatic
Brain Metastases
Non Small Cell Lung Cancer
Keywords: Positron Emission Tomography
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2022-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
timeFrame: Up to six months
Secondary outcomes:
measure: Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging
timeFrame: Up to six months
measure: Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging
timeFrame: Up to six months
measure: Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment
timeFrame: Up to six months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: The University of California Davis Comprehensive Cancer Center
state: California
Study officials:
affiliation: The Regents of the University of California (Davis)
name: Julie L. Sutcliffe, PhD
role: PRINCIPAL_INVESTIGATOR
References: