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.
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.
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
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There is 1 Location for this study
Sacramento California, 95817, United States More Info
Principal Investigator
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