Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer
Phase 1
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT04054986
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
The purpose of this study is to measure the safety of the investigational imaging agent, 18F-Var3 and to determine if it is helpful in providing information about how tumor tissues behave.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 6
Inclusion Criteria
- Age 18 years or greater
- Biopsy-proven breast malignancy
- >/= 1 viable lesion, >/= 1 cm, confirmed on CT, MR, or FDG PET/CT within 4 weeks of protocol enrollment
- Newly diagnosed or recurrent disease, on or off therapy
- ECOG performance of 0-2 *Note: Lesions are considered viable if they are stable or increasing soft tissue lesions, or if they are FDG-avid bone lesions
Exclusion Criteria
- Life expectancy < 3 months
- Pregnancy or lactation
- Biopsy or other surgical procedures within 48 hours prior to receiving study intervention
- Patients who cannot undergo PT/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 400 pounds
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0 30 days after completion of study treatment and assessments The safety of patients will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 and grade 2 toxicities are considered safe.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center🇺🇸New York, New York, United States