89ZrTrastuzumab Breast Imaging With Positron Emission Tomography
- Conditions
- Breast Cancer
- Interventions
- Drug: 89Zr-Trastuzumab Human Dosimetry and SafetyDrug: HER2 Positive Lesion Detection and Safety
- Registration Number
- NCT02065609
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 52
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 89Zr-Trastuzumab Human Dosimetry and Safety 89Zr-Trastuzumab Human Dosimetry and Safety Cohort 2: Lesion Detection and Safety HER2 Positive Lesion Detection and Safety HER2 Positive Lesion Detection and Safety Cohort 1 HER2 Positive Lesion Detection and Safety 89Zr-Trastuzumab Human Dosimetry and Safety Cohort 2: Lesion Detection and Safety 89Zr-Trastuzumab Human Dosimetry and Safety HER2 Positive Lesion Detection and Safety
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration 30 Days following 89Zr-Trastuzumab Administration Subjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Washington University School of Medicine @ Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States