Active — Not RecruitingEarly Phase 1

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

United States27 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Assessment of safe administration of 18F-αvβ6-BP

Timeframe: Up to 6 months

Trial details

NCT IDNCT03164486

SponsorJulie L. Sutcliffe, Ph.D

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

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