NCT00040430

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2002

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2003

First QC Date

June 26, 2002

Last Update Submit

June 23, 2005

Conditions

Breast Cancer

Interventions

111In-DACDRUG
DiagnosticPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

University at Buffalo

Buffalo, New York, 14214-3007, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2002

First Posted

June 28, 2002

Last Updated

June 24, 2005

Record last verified: 2003-01

Locations

US(2)