First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Assessment of safe administration of 18F-αvβ6-BP
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: 18F-αvβ6-BP (Drug)
Outcomes
Primary Outcomes
Assessment of safe administration of 18F-αvβ6-BP
Time Frame: Up to 6 months
Assessed by measures and/or changes in a given vital sign
Secondary Outcomes
- Measurement of 18F-αvβ6-BP accumulation in tumors(Up to 6 months)
- Level of αvβ6-BP expression in tumors(Up to 6 months)
Investigators
Julie L. Sutcliffe, Ph.D
Principal Investigator
University of California, Davis