Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments 111in-dac, diagnostic
Phase phase 1
Sponsor Copharos
Trial identifier NCT00040430, CP101

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Eligibility Criteria

Female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Copharos.