RECRUITING

Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.

Official Title

PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

Quick Facts

Study Start:2017-11-21
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03321045

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:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be at least 18 years of age.
  2. * Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number \>= 6 OR dual probe ISH with both average HER2 copy number \>= 4 AND HER2 to CEP17 ratio \>=2
  3. * Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1
  5. * Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans
  1. * Inability to provide informed consent
  2. * Pregnancy
  3. * Inability to lie still for the imaging study
  4. * Weight over 350 lbs., due to the scanner bore size
  5. * Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)

Contacts and Locations

Study Contact

Denise Jeffers, PharmD
CONTACT
205-975-6469
charlottejeffers@uabmc.edu
Sebastian Eady, BS
CONTACT
2059962636
smeady@uabmc.edu

Principal Investigator

Suzanne E Lapi, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

The Kirklin Clinic
Birmingham, Alabama, 35249
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Suzanne E Lapi, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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

Study Start Date2017-11-21
Study Completion Date2026-01

Study Record Updates

Study Start Date2017-11-21
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • 89Zr-Trastuzumab, HER2 Imaging

Additional Relevant MeSH Terms

  • Breast Cancer