Lung CancerPhase 1NCT05452005
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
A Phase 1 study testing [18F]-αvβ6-BP in people with Lung Cancer and Lung Cancer Metastatic, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Cancer Metastatic, Brain Metastases
- What is being tested?
- [18F]-αvβ6-BP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Julie L Sutcliffe, 916-734-5536, jlsutcliffe@ucdavis.edu
Megan Daly, MD
About this study
Official title: Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
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.
Read the 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.
- Being tested
- [18F]-αvβ6-BP
- Keywords
- Positron Emission Tomography
- Medical subject headings
- Lung Neoplasms, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-αvβ6-BPDrug
Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.
| Study group | Role | What they receive |
|---|---|---|
| Experimental [18F]-αvβ6-BP | Experimental | Patients receive [18F]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection. Receives: Drug: [18F]-αvβ6-BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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
Measured: Up to six months
Secondary outcomes (3)
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
Measured: Up to six months
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
Measured: 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
Lesion response will be assessed based on standard-of-care MRI images, [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT post treatment.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start13 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Julie L. Sutcliffe, Ph.D, University of California, Davis
- Investigators
- Julie L. Sutcliffe, PhD, Principal investigator, The Regents of the University of California (Davis)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452005
- Sponsor's protocol ID
- 1718953
- Status last verified
- Feb 2026
- First submitted
- 28 Jun 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05452005
- Acronym / sponsor ID
- 1718953
- Keywords
- Positron Emission Tomography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental [18F]-αvβ6-BP | Experimental | Drug: [18F]-αvβ6-BPPatients receive [18F]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-αvβ6-BPSubjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus. | Drug | Experimental [18F]-αvβ6-BP |
Primary outcome
[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
Time frame: 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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie L. Sutcliffe, PhD principal investigator
The Regents of the University of California (Davis)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]-αvβ6-BP in people with Lung Cancer and Lung Cancer Metastatic, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (916-734-5536, jlsutcliffe@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry (time frame: Up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.