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

Early Phase 1Active Not RecruitingNCT03164486

Julie L. Sutcliffe, Ph.D27 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Carcinoma Colorectal Carcinoma Lung Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Assessment of safe administration of 18F-αvβ6-BP

Assessed by measures and/or changes in a given vital sign

Time frame: Up to 6 months

Secondary Outcomes

Measurement of 18F-αvβ6-BP accumulation in tumors

Assessed by PET

Time frame: Up to 6 months

Level of αvβ6-BP expression in tumors

Immunohistochemistry (IHC) staining for the cell surface receptor integrin

Time frame: Up to 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes