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

• Sponsor: University of California, Davis (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05452005
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Lung Cancer Metastatic; Brain Metastases; Non Small Cell Lung Cancer	Drug: [18F]-αvβ6-BP	Phase 1

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

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: May 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental [18F]-αvβ6-BP 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; Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.

Outcome Measures

Primary Outcome Measures

1. [18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry [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

Secondary Outcome Measures

1. Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging [Up to six months]

   Detection of lesions with [18F]-αvβ6-BP will be compared to the number of lesions identified during standard-of-care MRI imaging

2. Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging [Up to six months]

   SUVmax values obtained during standard-of-care FDG/PET will be compared to SUVmax values obtained from [18F]-αvβ6-BP PET/CT imaging

3. 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]

   Lesion response will be assessed based on standard-of-care MRI images, [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT post treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of California Davis Comprehensive Cancer Center	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis
• United States Department of Defense

Investigators

• Principal Investigator: Julie L. Sutcliffe, PhD, The Regents of the University of California (Davis)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julie L. Sutcliffe, Ph.D, Professor of Internal Medicine and Biomedical Engineering, University of California, Davis
• ClinicalTrials.gov Identifier: NCT05452005
• Other Study ID Numbers: 1718953
• First Posted: Jul 11, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Julie L. Sutcliffe, Ph.D, Professor of Internal Medicine and Biomedical Engineering, University of California, Davis: Positron Emission Tomography
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Study Results

No Results Posted as of Aug 5, 2022