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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Drug: 18F-αvβ6-BP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-αvβ6-BP<br>Patients receive 18F-alphavbeta6-BP IV and then undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection. | Drug: 18F-αvβ6-BP<br>* Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds).<br>* Other names: Image Enhancement Agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safe administration of 18F-αvβ6-BP | Assessed by measures and/or changes in a given vital sign | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of 18F-αvβ6-BP accumulation in tumors | Assessed by PET | Up to 6 months | 
| Level of αvβ6-BP expression in tumors | Immunohistochemistry (IHC) staining for the cell surface receptor integrin | Up to 6 months |