Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion
Julie Sutcliffe (ucdavis)

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVES:

  1. 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.

Keywords

Breast CarcinomaColorectal CarcinomaLung CarcinomaMetastatic Malignant Neoplasm in the BreastMetastatic Malignant Neoplasm in the ColonMetastatic Malignant Neoplasm in the LungMetastatic Malignant Neoplasm in the RectumPancreatic CarcinomaCarcinomaNeoplasmsBreast NeoplasmsLung NeoplasmsColorectal NeoplasmsPancreatic NeoplasmsNeoplasms, Second Primary18F-αvβ6-BP

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Location

  • University of California Davis Comprehensive Cancer Center accepting new patients
    SacramentoCalifornia95817United States

Lead Scientist

  • Julie Sutcliffe (ucdavis)
    Authored (or co-authored) 18 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT03164486
Phase
Phase 1
Study Type
Interventional
Last Updated