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First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide

Primary Purpose

Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-αvβ6-BP
Sponsored by
Julie L. Sutcliffe, Ph.D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
  • Will sign the Institutional Review Board (IRB)-approved consent form
  • Able to remain motionless for up to 30-60 minutes per scan

Exclusion Criteria:

  • Creatinine > 2 x upper limit of normal
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal
  • Life expectancy < 3 months (mo)
  • Women who are pregnant or breast-feeding
  • Patients who cannot undergo PET/compute tomography (CT) scanning
  • Lack of availability for follow-up assessments
  • Participation in another clinical trial involving an investigational agent within 4 weeks of enrollment

Sites / Locations

  • University of California Davis Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-αvβ6-BP

Arm Description

Patients receive 18F-alphavbeta6-BP IV and then undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.

Outcomes

Primary Outcome Measures

Assessment of safe administration of 18F-αvβ6-BP
Assessed by measures and/or changes in a given vital sign

Secondary Outcome Measures

Measurement of 18F-αvβ6-BP accumulation in tumors
Assessed by PET
Level of αvβ6-BP expression in tumors
Immunohistochemistry (IHC) staining for the cell surface receptor integrin

Full Information

First Posted
May 22, 2017
Last Updated
February 3, 2023
Sponsor
Julie L. Sutcliffe, Ph.D
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03164486
Brief Title
First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
Official Title
First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie L. Sutcliffe, Ph.D
Collaborators
National Cancer Institute (NCI)

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 clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety, biodistribution and dosimetric properties of 18F-alphavbeta6-binding peptide (BP) in normal tissues and malignancies in cancer patients and correlate concordance with alphavbeta6 expression. OUTLINE: Patients receive 18F-alphavbeta6-BP intravenously (IV) and then undergo positron emission tomography (PET) scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection. After completion of study, patients are followed up for up to 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Metastatic Malignant Neoplasm in the Breast, Metastatic Malignant Neoplasm in the Colon, Metastatic Malignant Neoplasm in the Lung, Metastatic Malignant Neoplasm in the Rectum, Pancreatic Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
18F-αvβ6-BP
Arm Type
Experimental
Arm Description
Patients receive 18F-alphavbeta6-BP IV and then undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.
Intervention Type
Drug
Intervention Name(s)
18F-αvβ6-BP
Other Intervention Name(s)
Image Enhancement Agent
Intervention Description
Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds).
Primary Outcome Measure Information:
Title
Assessment of safe administration of 18F-αvβ6-BP
Description
Assessed by measures and/or changes in a given vital sign
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Measurement of 18F-αvβ6-BP accumulation in tumors
Description
Assessed by PET
Time Frame
Up to 6 months
Title
Level of αvβ6-BP expression in tumors
Description
Immunohistochemistry (IHC) staining for the cell surface receptor integrin
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas Eastern Cooperative Oncology Group (ECOG) performance score of 0-1 Will sign the Institutional Review Board (IRB)-approved consent form Able to remain motionless for up to 30-60 minutes per scan Exclusion Criteria: Creatinine > 2 x upper limit of normal Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal Life expectancy < 3 months (mo) Women who are pregnant or breast-feeding Patients who cannot undergo PET/compute tomography (CT) scanning Lack of availability for follow-up assessments Participation in another clinical trial involving an investigational agent within 4 weeks of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Sutcliffe
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Learn more about this trial

First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide

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