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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2003 by Copharos. Recruitment status was Active, not recruiting

First Received on June 26, 2002. Last Updated on 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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Copharos:

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

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

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012