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

Copharos

Status and phase

Unknown

Phase 1

Conditions

Breast Cancer

Treatments

Procedure: Diagnostic

Drug: 111In-DAC

Study type

Interventional

Funder types

Industry

Identifiers

NCT00040430

CP101

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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