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Related Studies
Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: June 26, 2002   Last Updated: June 23, 2005   History of Changes
Sponsor: Copharos
Information provided by: Copharos
ClinicalTrials.gov Identifier: NCT00040430
  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 Intervention Phase
Breast Cancer
Drug: 111In-DAC
Procedure: Diagnostic
Phase I

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040430

Locations
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
Sponsors and Collaborators
Copharos
  More Information

No publications provided

Study ID Numbers: CP101
Study First Received: June 26, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00040430     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009