Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
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ClinicalTrials.gov Identifier: NCT00040430 |
Recruitment Status
: Unknown
Verified January 2003 by Copharos.
Recruitment status was: Active, not recruiting
First Posted
: June 28, 2002
Last Update Posted
: June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: 111In-DAC Procedure: Diagnostic | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040430
United States, California | |
Sutter Roseville Medical Center | |
Roseville, California, United States, 95661 | |
United States, New York | |
University at Buffalo | |
Buffalo, New York, United States, 14214-3007 |
ClinicalTrials.gov Identifier: | NCT00040430 History of Changes |
Other Study ID Numbers: |
CP101 |
First Posted: | June 28, 2002 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | January 2003 |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |