Breast Cancer
Conditions
Brief summary
The 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.
Interventions
DRUG111In-DAC
PROCEDUREDiagnostic
Sponsors
Copharos
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed