ClinicalTrials.gov
ClinicalTrials.gov Menu

89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02065609
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: 89Zr-Trastuzumab Human Dosimetry and Safety Drug: HER2 Positive Lesion Detection and Safety Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of HER2 Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using 89 Zr-Trastuzumab
Study Start Date : February 2014
Actual Primary Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065609


Locations
United States, Missouri
Washington University School of Medicine @ Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
Principal Investigator: Farrokh Dehdashti, MD Washington University School of Medicine

Responsible Party: Farrokh Dehdashti, Profesior of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02065609     History of Changes
Other Study ID Numbers: 201307037
R21CA182945 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Keywords provided by Farrokh Dehdashti, Washington University School of Medicine:
Trastuzumab

Additional relevant MeSH terms:
Trastuzumab
Antineoplastic Agents