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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03164486
• Other study ID #: 970652
• Secondary ID: NCI-2017-00411CC
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: November 2016
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• 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
• Neoplasms
• Neoplasms, Second Primary
• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• 18F-avß6-BP
Subjects will be injected once with up to 10 mCi of 18F-avß6-BP as a rapid intravenous bolus (within 30 seconds).

Locations

Country	Name	City	State
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Julie L. Sutcliffe, Ph.D	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safe administration of 18F-avß6-BP	Assessed by measures and/or changes in a given vital sign	Up to 6 months
Secondary	Measurement of 18F-avß6-BP accumulation in tumors	Assessed by PET	Up to 6 months
Secondary	Level of avß6-BP expression in tumors	Immunohistochemistry (IHC) staining for the cell surface receptor integrin	Up to 6 months