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

Study Overview

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

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.

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.

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

970652
NCI-2017-00411 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
CCHO028 (OTHER Identifier) (OTHER: University of California Davis Comprehensive Cancer Center)
P30CA093373 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-05-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-21
First Submitted that Met QC Criteria 2017-05-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-23
First Posted (ACTUAL) 2017-05-23	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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).

Participant Group/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).

Primary Outcome Measures	Measure Description	Time Frame
Assessment of safe administration of 18F-αvβ6-BP	Assessed by measures and/or changes in a given vital sign	Up to 6 months

Secondary Outcome Measures	Measure Description	Time Frame
Measurement of 18F-αvβ6-BP accumulation in tumors	Assessed by PET	Up to 6 months
Level of αvβ6-BP expression in tumors	Immunohistochemistry (IHC) staining for the cell surface receptor integrin	Up to 6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Julie Sutcliffe, University of California, Davis

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record