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

Julie L. Sutcliffe, Ph.D

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Breast; Metastatic Malignant Neoplasm in the Rectum; Lung Carcinoma; Metastatic Malignant Neoplasm in the Lung; Breast Carcinoma; Metastatic Malignant Neoplasm in the Colon; Pancreatic Carcinoma

Treatments: Drug: 18F-αvβ6-BP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03164486

CCHO028 (Other Identifier)

P30CA093373 (U.S. NIH Grant/Contract)

970652

NCI-2017-00411 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

18F-αvβ6-BP

Experimental group

Description:

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.

Treatment:

Drug: 18F-αvβ6-BP