Suspended

A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.

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What is being collected

Data Collection

Collected from today forward - Prospective
Other
Who is being recruted

Over 45 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: November 2004
See protocol details

Summary

Principal SponsorSt. Vincent's Medical Center
Study ContactDeborah Fang, MDMore contacts
Last updated: March 19, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2004

Actual date on which the first participant was enrolled.

PURPOSE OF STUDY The patient understand that she has cancer of the breast. The patient understand that is offered the opportunity to participate in a registry study to collect data on the FDA approved device,Partial Breast Brachytherapy Applicator. Partial Breast Brachytherapy is a treatment method that works by delivering radiation from inside the breast directly to the tissue where cancer is most likely to recur. The Partial Breast Brachytherapy Applicator is a device that has tiny catheters or wires that fit inside the lumpectomy cavity (the space left after the tumor is removed). Radioactive sources (seed) are placed within the device by a computer controlled machine. This radioactive source will deliver the radiation therapy to the breast A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases. PROCEDURES If the patient agree to take part in this registry, data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits. POTENTIAL RISKS AND DISCOMFORTS There is no medical risk to the patient if she takes part in this registry, as she will continue to receive the same medical care as provided by her medical team. POTENTIAL BENEFITS: It is not possible to state that the patient will benefit from this study. The information obtained from study may be used scientifically and may possibly be helpful to others. ALTERNATIVES TO TREATMENT The patient participation is voluntary and she may choose not to participate in this study or she may stop at any time. The patient choice will not affect doctors from providing care. The patient will not lose any benefits if she choose not to participate or if you withdraw from this study. She is free to seek care from a doctor of her choice at any time.

Principal SponsorSt. Vincent's Medical Center
Study ContactDeborah Fang, MDMore contacts
Last updated: March 19, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Be 45 years of age or older

Be a Tis, T1, N0 M0 - American Joint Committee Classification

DCIS

Have negative surgical margins (NSABP definition) after final surgery

Show More Criteria

4 exclusion criteria prevent from participating
Be pregnant or breast-feeding.(If appropriate, patient must use birth control during the study)

Have collagen-vascular disease

Have extensive intraductal component (Harvard Definition, > 25% DCIS)

Have infiltrating lobular histology

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

St. Vincent's Medical Center

Bridgeport, United StatesOpen St. Vincent's Medical Center in Google Maps
SuspendedOne Study Center