Contura – Multi-Lumen Balloon Applicator

A Simple Way To Deliver Radiation From The Inside

The Contura balloon was an early form of APBI, a minimally invasive method of delivering internal radiation therapy following a lumpectomy for breast cancer. Therapy is given on an outpatient basis, so there is no need for a hospital stay and the treat can be completed in 5 days.

The Contura is a single small balloon catheter than (A) fits inside the tumor resective cavity (the space left after the surgeon has removed the tumor). A tiny radioactive seed (B), connected to a machine called an afterloader (C), is inserted into the balloon and delivers the radiation therapy

This focuses the radiation dose on the area of the breast at highest risk for tumor recurrence. Radiation therapy with this device is preformed over a period of 1 – 5 days. When used alone, patients typically receive treatment twice a day for 5 days.

This process has three important advantages:

  • It places the radiation inside the lumpectomy cavity (the space left when a tumor is removed). The radiation is targeted to the area where cancer is most likely to recur.
  • Radiation is delivered from the within the cavity, limiting the amount or radiation to healthy surrounding tissue, thereby reducing the potential for side effects to occur.
  • The therapy can be completed in 5 days in an out patient setting.

 

The Procedure

After lumpectomy, an uninflated balloon is placed inside the tumor resective cavity. The applicator shaft, a tube connected to the balloon, remains outside the breast (Figure 1). Once in place, the balloon is inflated with saline (sterile salt water) and a contrast agent, inserted through the applicator. (The contrast agent helps your doctor see the MammoSite balloon more clearly.) The balloon is filled to fit the edges of the cavity (Figure 2). The balloon will remain inflated for the entire time you are receiving radiation therapy.

Contura Breast Cancer TreatmentFigure 1

  • After tumor removal surgery, an uninflated balloon is placed inside the tumor resection cavity.

Clinical Findings: The Contura has been carefully evaluated in a clinical trial. Following treatment, patients did experience minor breast-related side effects such as redness, bruising and breast pain. All of these are common side effects of breast surgery and/or radiation therapy. They usually last for only a short time. Some patients also experienced drainage from the insertion site.

Contura Breast Cancer TreatmentFigure 2

  • Once in place, the balloon is inflated with saline and a contrast agent, inserted through the applicator catheter.

By placing the balloon inside the tumor resection cavity, the radiation source will be directly next to the area of the breast that is at the highest risk for tumor recurrence.

The Contura can be inserted either:

  • During the lumpectomy procedure (at the time of the tumor removal)
  • In a separate procedure under local anesthesia up to 10 weeks after the lumpectomy.

After the balloon is inserted, that area of the breast is cleaned, bandaged and you may return home. Radiation therapy can now begin under the direction of your physician.

Once The Balloon Is Placed, Radiation Therapy Can Begin

Treatment with the Contura is given on an outpatient basis and does not require a hospital stay. Your radiation oncologist will develop a radiation plan customized for you. When used alone, typical treatment with the Contura would require 2 brief appointments a day for 5 days. If used as a boost inconjunction with external beam radiation, the Contura would require 2 brief appointments for only 1 day.

Radiation is emitted by a tiny radioactive seed attached by a wire to an afterloader. The afterloader is a computer-controlled machine that houses the radioactive source. The seed travels through the applicator into the inflated balloon (Figure 3). Where the seeds goes and how much radiation is released is carefully determined by your radiation oncologist to effectively treat the cancer.

Contura Breast Cancer TreatmentFigure 3

  • A radioactive seed attached to a wire delivers a precise dose of radiation

No source of radiation remains in your body between treatments or after the final treatment is completed. The tiny radioactive seed is only inserted during your treatment and is removed upon complete of your treatment. Neither the balloon nor the liquid inside is or will be radioactive in any way.

Once the final session is completed, the balloon is deflated and the Contura is easily removed. In most cases, you will not even require anesthesia for the removal (Figure 4).

Contura Breast Cancer TreatmentFigure 4

  • After radiation treatment is completed, the balloon is deflated and removed.

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