CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Mammosite brachytherapy radiationradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00611624
NCT00611624N/ACompleted
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A Phase II Trial of Mammosite Breast Brachytherapy Optimization in the Treatment of Stage 0, I and II Breast Carcinoma

Yale University·interventional·Posted Feb 11, 2008·Updated May 16, 2017

In Brief

A clinical study evaluating Mammosite brachytherapy radiation for Breast Neoplasms. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if Mammosite Catheter optimization using multiple dwell position delivery decreases skin toxicity over historically reported skin toxicity with the single dwell delivery method.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 11, 2008
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 18.4 years ago

Interventions

Mammosite brachytherapy radiationradiation

Treatment using MammoSite will begin within five days of placement of the catheter. Only high dose rate (HDR) with Ir-192 treatment is allowed. The balloon will remain inflated throughout the treatment course. A total of 34 Gy will be prescribed to an approximate 1 cm radial distance from the balloon surface. Two fractions per day, each of 3.4 Gy, separated by at least 6 hours, given on 5 treatment days (over a period of 5 to 10 days), will sum to 10 fractions and 34 Gy.