89ZrTrastuzumab Breast Imaging With Positron Emission Tomography
NCT ID: NCT02065609
Last Updated: 2022-10-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
52 participants
INTERVENTIONAL
2014-02-28
2018-02-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients
NCT01420146
Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
NCT01937117
HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer
NCT06595563
Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
NCT00006104
Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer
NCT03112590
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
89Zr-Trastuzumab Human Dosimetry and Safety
89Zr-Trastuzumab Human Dosimetry and Safety
PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety
Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
Cohort 2: Lesion Detection and Safety
HER2 Positive Lesion Detection and Safety
89Zr-Trastuzumab Human Dosimetry and Safety
PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety
Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
89Zr-Trastuzumab Human Dosimetry and Safety
PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
HER2 Positive Lesion Detection and Safety
Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Unable to tolerate 60 min of PET imaging per imaging session
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Farrokh Dehdashti
Professor of Radiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Farrokh Dehdashti, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine @ Barnes-Jewish Hospital
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201307037
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.