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

NCT03164486 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 4 other identifiers: 970652NCI-2017-00411CCHO028P30CA093373
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Assessment of safe administration of 18F-αvβ6-BP

  Assessed by measures and/or changes in a given vital sign

  Up to 6 months

Secondary Outcomes (2)

• Measurement of 18F-αvβ6-BP accumulation in tumors

  Up to 6 months

• Level of αvβ6-BP expression in tumors

  Up to 6 months

Study Arms (1)

18F-αvβ6-BP

EXPERIMENTAL

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

Interventions

18F-αvβ6-BP DRUG

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

Also known as: Image Enhancement Agent

18F-αvβ6-BP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Julie L. Sutcliffe, Ph.D: lead

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Julie Sutcliffe

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 23, 2017
• Study Start: November 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)