Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
[18F]-αvβ6-BP
DrugSubjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Experimental [18F]-αvβ6-BPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
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
Time frame
Up to six monthsSecondary outcomes
1
Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging
Detection of lesions with \[18F\]-αvβ6-BP will be compared to the number of lesions identified during standard-of-care MRI imaging
Time frame
Up to six months2
Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging
SUVmax values obtained during standard-of-care FDG/PET will be compared to SUVmax values obtained from \[18F\]-αvβ6-BP PET/CT imaging
Time frame
Up to six months3
Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment
Lesion response will be assessed based on standard-of-care MRI images, \[18F\]-FDG PET/CT and \[18F\]-αvβ6-BP PET/CT post treatment.
Time frame
Up to six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov