89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02065609
First received: February 5, 2014
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: 89Zr-Trastuzumab Human Dosimetry and Safety
Drug: HER2 Positive Lesion Detection and Safety
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of HER2 Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using 89 Zr-Trastuzumab

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability after 89Zr-Trastuzumab Administration [ Time Frame: 30 Days following 89Zr-Trastuzumab Administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 52
Study Start Date: February 2014
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
89Zr-Trastuzumab Human Dosimetry and Safety
Drug: 89Zr-Trastuzumab Human Dosimetry and Safety
PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
Drug: HER2 Positive Lesion Detection and Safety
Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
Experimental: Cohort 2: Lesion Detection and Safety
HER2 Positive Lesion Detection and Safety
Drug: 89Zr-Trastuzumab Human Dosimetry and Safety
PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
Drug: HER2 Positive Lesion Detection and Safety
Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients 18 years of age or older
  • Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 biopsy proven breast cancer
  • Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 OR HER2negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer
  • Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
  • Able to give informed consent
  • Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 89Zr-trastuzumab) is negative
  • Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion(s) or worsening of known lesion(s) based on imaging modalities or physical examination.

Exclusion Criteria:

  • Patients with other invasive malignancies, with the exception of non- melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
  • Unable to tolerate 60 min of PET imaging per imaging session
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065609

Contacts
Contact: Jennifer Frye, CNMT, PET, CCRC 314-747-1604 fryej@mir.wustl.edu
Contact: Sarah Frye, MBA, CNMT, PET, NCT 314-362-7026 fryes@mir.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine @ Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jennifer Frye, CNMT, PET, CCRC    314-747-1604    fryej@mir.wustl.edu   
Contact: Sarah Frye, MBA, CNMT, PET, NCT    314-362-7026    fryes@mir.wustl.edu   
Principal Investigator: Farrokh Dehdashti, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Farrokh Dehdashti, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Farrokh Dehdashti, Profesior of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02065609     History of Changes
Other Study ID Numbers: 20130737, R21CA182945
Study First Received: February 5, 2014
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014