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Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients

NCT00882089 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-01-25

No results posted yet for this study

Summary

The purpose of this study is to determine if a Contura catheter can avoid a radiation "hot spot" in the skin and improve tissue-balloon conformance in early-stage breast cancer patients undergoing accelerated partial breast irradiation.

Conditions

Interventions

DEVICE

Contura catheter

Radiation therapy is delivered to a total dose of 34 Gy in 10 fractions bid over 5-7 days. Each day, the high dose rate iridium-192 brachytherapy treatments are separated by 6 hours. Each radiation treatment takes 15-30 minutes.

Sponsors & Collaborators

  • SenoRx, Inc.

    collaborator INDUSTRY

  • Cancer Center of Irvine

    lead OTHER

Principal Investigators

  • Richard B Wilder, MD · Cancer Center of Irvine

  • Kenneth M Tokita, MD · Cancer Center of Irvine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00882089 on ClinicalTrials.gov