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

Primary Purpose

Lung Cancer, Lung Cancer Metastatic, Brain Metastases

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]-αvβ6-BP
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Positron Emission Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of California Davis Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental [18F]-αvβ6-BP

Arm Description

Patients receive [18F]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.

Outcomes

Primary Outcome Measures

[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

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
June 28, 2022
Last Updated
September 19, 2022
Sponsor
University of California, Davis
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05452005
Brief Title
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography in Metastatic Non-Small Cell Lung Cancer
Official Title
Fluorine-18-AlphaVBeta6-Binding Peptide Positron Emission Tomography for Staging, Response Assessment, and Patient Selection in Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Lung Cancer Metastatic, Brain Metastases, Non Small Cell Lung Cancer
Keywords
Positron Emission Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental [18F]-αvβ6-BP
Arm Type
Experimental
Arm Description
Patients receive [18F]-αvβ6-BP BP IV and then undergo a PET/CT scan over 30 minutes 60 minutes post-injection.
Intervention Type
Drug
Intervention Name(s)
[18F]-αvβ6-BP
Intervention Description
Subjects will be injected twice with up to 10 millicurie (mCi) of 18F-αvβ6-BP as a rapid intravenous (i.v) bolus.
Primary Outcome Measure Information:
Title
[18F]-αvβ6-BP PET/CT imaging compared to immunohistochemistry
Description
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 months
Secondary Outcome Measure Information:
Title
Comparison of standard-of-care MRI and [18F]-αvβ6-BP PET/CT imaging
Description
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 months
Title
Comparison of standard-of-care [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging
Description
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 months
Title
Comparison of standard-of-care MRI brain and [18F]-FDG PET/CT and [18F]-αvβ6-BP PET/CT imaging post treatment
Description
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 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Principal Investigator
Phone
916-734-5536
Email
jlsutcliffe@ucdavis.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie L Sutcliffe
Phone
9167345536
Email
jlsutcliffe@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie L. Sutcliffe, PhD
Organizational Affiliation
The Regents of the University of California (Davis)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie L Sutcliffe
Phone
916-734-5536
Email
jlsutcliffe@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Megan Daly, MD

12. IPD Sharing Statement

Learn more about this trial

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

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