Title
Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
Phase
Phase 1Lead Sponsor
CopharosStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Breast CancerIntervention/Treatment
111in-daclizumab ...Study Participants
NoneThe purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of breast cancer.
Inclusion Criteria Patients will be eligible for the study if they: Are non-pregnant, non-lactating females 18 years of age or older(must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study) Are being evaluated for a known or suspected breast tumor (must present with either a mammographic abnormality 10mm or larger or a mammographically occult but palpable abnormality of the breast) Have been previously scheduled for biopsy or surgical excision of the known or suspected tumor of the breast Have signed an informed consent form Exclusion Criteria Patients will not be eligible for this study if they: Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed Are taking or have taken part in any investigational study within 30 days of start of study Have received an indium agent within 30 days of start of study Are not able to remain immobile during scanning time Have taken drugs that may damage the kidneys within 2 weeks of start of study Have abnormal laboratory test results: hemoglobin < 9.5 gms/dl, serum creatinine > 1.5 mg/100ml, alkaline phosphatase 2X the upper limit of normal Have undergone an excisional and/or needle localization biopsy within 4 days prior to start of study