Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452005
• Other study ID #: 1718953
• Status: Recruiting
• Phase: Phase 1
• Start date: September 13, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of California, Davis
• Contact: Principal Investigator
• Phone: 916-734-5536
• Email: jlsutcliffe[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Cancer Metastatic
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• [18F]-avß6-BP
Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-avß6-BP as a rapid intravenous (i.v) bolus.

Locations

Country	Name	City	State
United States	The University of California Davis Comprehensive Cancer Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[18F]-avß6-BP PET/CT imaging compared to immunohistochemistry	Standard uptake value (SUV) values from [18F]-avß6-BP PET/CT will be compared to immunohistochemistry (IHC) avß6 staining of archival tissue to assess the sensitivity of [18F]-avß6-BP PET/CT to detect avß6 positive metastasis in NSCLC	Up to six months
Secondary	Comparison of standard-of-care MRI and [18F]-avß6-BP PET/CT imaging	Detection of lesions with [18F]-avß6-BP will be compared to the number of lesions identified during standard-of-care MRI imaging	Up to six months
Secondary	Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-avß6-BP PET/CT imaging	SUVmax values obtained during standard-of-care FDG/PET will be compared to SUVmax values obtained from [18F]-avß6-BP PET/CT imaging	Up to six months
Secondary	Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-avß6-BP PET/CT imaging post treatment	Lesion response will be assessed based on standard-of-care MRI images, [18F]-FDG PET/CT and [18F]-avß6-BP PET/CT post treatment.	Up to six months