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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00040430
• Other study ID #: CP101
• Status: Active, not recruiting
• Phase: Phase 1
• First received: June 26, 2002
• Last updated: June 23, 2005

Study information

• Verified date: January 2003
• Source: Copharos
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• 111In-DAC

Procedure:
• Diagnostic

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York
United States	Sutter Roseville Medical Center	Roseville	California

Sponsors (1)

Lead Sponsor	Collaborator
Copharos

Country where clinical trial is conducted

United States,