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

February 23, 2026 updated by: Julie L. Sutcliffe, Ph.D
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-αvβ6-BP
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.
Drug: 18F-αvβ6-BP
Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds).
Other Names:
  • Image Enhancement Agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of safe administration of 18F-αvβ6-BP
Time Frame: Up to 6 months
Assessed by measures and/or changes in a given vital sign
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of 18F-αvβ6-BP accumulation in tumors
Time Frame: Up to 6 months
Assessed by PET
Up to 6 months
Level of αvβ6-BP expression in tumors
Time Frame: Up to 6 months
Immunohistochemistry (IHC) staining for the cell surface receptor integrin
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julie L. Sutcliffe, Ph.D

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Julie Sutcliffe, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970652
  • P30CA093373 (U.S. NIH Grant/Contract)
  • NCI-2017-00411 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CCHO028 (Other Identifier: University of California Davis Comprehensive Cancer Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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