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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2003 by Copharos.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Copharos
ClinicalTrials.gov Identifier:
NCT00040430
First received: June 26, 2002
Last updated: June 23, 2005
Last verified: January 2003

June 26, 2002
June 23, 2005
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Complete list of historical versions of study NCT00040430 on ClinicalTrials.gov Archive Site
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Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
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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.

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Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Drug: 111In-DAC
  • Procedure: Diagnostic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00040430
CP101
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Copharos
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Copharos
January 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP