NCT05452005

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 lung-cancer

Timeline
8mo left

Started Sep 2022

Typical duration for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

June 28, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 13, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

June 28, 2022

Last Update Submit

February 23, 2026

Conditions

Lung Cancer MetastaticBrain MetastasesNon Small Cell Lung CancerLung Cancer

Keywords

Positron Emission Tomography

Outcome Measures

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

    Up to six months

Secondary Outcomes (3)

  • Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging

    Up to six months

  • Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging

    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

    Up to six months

Study Arms (1)

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.

Drug: [18F]-αvβ6-BP

Interventions

[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.

Experimental [18F]-αvβ6-BP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsBrain NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Julie L. Sutcliffe, PhD

    The Regents of the University of California (Davis)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

916-734-5536jlsutcliffe@ucdavis.edu

Julie L Sutcliffe

CONTACT

9167345536jlsutcliffe@ucdavis.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine and Biomedical Engineering

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 11, 2022

Study Start

September 13, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(1)