Diagnostic Tests |
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Clinical Trial: Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
This study is no longer recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Breast Cancer | Drug: 111In-DAC Procedure: Diagnostic | Phase I |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
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
Location Information
California
Sutter Roseville Medical Center, Roseville, California, 95661, United States
New York
University at Buffalo, Buffalo, New York, 14214-3007, United States
More Information
Record last reviewed: January 2003
Last Updated: October 13, 2004
Record first received: June 26, 2002
ClinicalTrials.gov Identifier: NCT00040430
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Colonoscopy (National Institute of Diabetes and Digestive and Kidney Diseases)
- Diagnostic Tests (National Institute of Diabetes and Digestive and Kidney Diseases)

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