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

NCT ID: NCT03164486

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

18F-αvβ6-BP

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

Image Enhancement Agent

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Julie L. Sutcliffe, Ph.D

OTHER

Sponsor Role: lead

Responsible Party

Julie L. Sutcliffe, Ph.D

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Julie Sutcliffe

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Countries

United States

Other Identifiers

NCI-2017-00411

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCHO028

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA093373

Identifier Type: NIH

Identifier Source: secondary_id

View Link

970652

Identifier Type: -

Identifier Source: org_study_id