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

Tracking Information
First Received Date ^ICMJE	June 26, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Drug: 111In-DAC Procedure: Diagnostic
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00040430
Responsible Party
Study ID Numbers ^ICMJE	CP101
Study Sponsor ^ICMJE	Copharos
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Copharos
Verification Date	January 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP