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Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer



Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer

For Condition: Breast Cancer
Status: No longer recruiting
Sponsor(s): Copharos ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Sutter Roseville Medical Center
Roseville,  California,  95661
United States
 

University at Buffalo
Buffalo,  New York,  14214-3007
United States
 


Additional Information:
Study ID Numbers:  CP101; 
Study Start Date: 
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040430

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