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

Sponsor

Julie L. Sutcliffe, Ph.D (Other)

Overall Status

Recruiting

CT.gov ID

NCT03164486

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: 18F-αvβ6-BP	Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 18F-αvβ6-BP 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 Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds). Other Names: Image Enhancement Agent

Arm

Intervention/Treatment

Experimental: 18F-αvβ6-BP

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

Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds).

Other Names:

Image Enhancement Agent

Outcome Measures

Primary Outcome Measures

Assessment of safe administration of 18F-αvβ6-BP [Up to 6 months]
Assessed by measures and/or changes in a given vital sign

Secondary Outcome Measures

Measurement of 18F-αvβ6-BP accumulation in tumors [Up to 6 months]
Assessed by PET
Level of αvβ6-BP expression in tumors [Up to 6 months]
Immunohistochemistry (IHC) staining for the cell surface receptor integrin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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