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

NCT03164486•Julie L. Sutcliffe, Ph.D

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Key Dates

Start Date

November 1, 2016

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Breast CarcinomaColorectal CarcinomaLung CarcinomaMetastatic Malignant Neoplasm in the BreastMetastatic Malignant Neoplasm in the ColonMetastatic Malignant Neoplasm in the LungMetastatic Malignant Neoplasm in the RectumPancreatic Carcinoma

Interventions

18F-αvβ6-BP

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform