Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
Status unconfirmed · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00040430
- Run by
- Copharos
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sutter Roseville Medical Center — Roseville, California, United States
- University at Buffalo — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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