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

Early Phase 1

Active, not recruiting

• Conditions: Pancreatic Carcinoma; Metastatic Malignant Neoplasm in the Lung; Breast Carcinoma; Colorectal Carcinoma; Lung Carcinoma; Metastatic Malignant Neoplasm in the Breast; Metastatic Malignant Neoplasm in the Colon; Metastatic Malignant Neoplasm in the Rectum
• Interventions: Drug: 18F-αvβ6-BP

• Registration Number: NCT03164486
• Lead Sponsor: Julie L. Sutcliffe, Ph.D

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-αvβ6-BP	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of California Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States