NCT03164486

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Julie L. Sutcliffe, Ph.D · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2016-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2017-05-23
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study