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

Sponsors

Lead sponsor: Copharos

Source Copharos
Brief Summary

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.

Overall Status Unknown status
Phase Phase 1
Study Type Interventional
Condition
Intervention

Intervention type: Drug

Intervention name: 111In-DAC

Intervention type: Procedure

Intervention name: Diagnostic

Eligibility

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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Sutter Roseville Medical Center | Roseville, California, 95661, United States
University at Buffalo | Buffalo, New York, 14214-3007, United States
Location Countries

United States

Verification Date

January 2003

Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov