Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

27

Study ID:

NCT03164486

Recruitment Status:

Recruiting

Sponsor:

Julie L. Sutcliffe, Ph.D

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There is 1 Location for this study

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University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Julie Sutcliffe
Contact
916-734-5536
[email protected]
Julie Sutcliffe
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

27

Study ID:

NCT03164486

Recruitment Status:

Recruiting

Sponsor:


Julie L. Sutcliffe, Ph.D

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