Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03164486

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Carcinoma Lung Diseases Lung Neoplasms Metastatic Malignant Neoplasm in the Breast Metastatic Malignant Neoplasm in the Colon Metastatic Malignant Neoplasm in the Lung Metastatic Malignant Neoplasm in the Rectum Neoplasms Neoplasms by Site Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-αvβ6-BP

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Measurement of 18F-αvβ6-BP accumulation in tumors

    Time frame: Up to 6 months

    Assessed by PET

  2. Level of αvβ6-BP expression in tumors

    Time frame: Up to 6 months

    Immunohistochemistry (IHC) staining for the cell surface receptor integrin

Sponsors and collaborators

Lead sponsor

Julie L. Sutcliffe, Ph.D

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
May 23, 2017
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.