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Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Authority:

United States: Food and Drug Administration

Study ID:

CP101

NCT ID:

NCT00040430

Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Sutter Roseville Medical CenterRoseville, California  95661
University at BuffaloBuffalo, New York  14214-3007