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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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111In-DAC

Intervention Type DRUG

Diagnostic

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Locations

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Sutter Roseville Medical Center

Roseville, California, United States

Site Status

University at Buffalo

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CP101

Identifier Type: -

Identifier Source: org_study_id