Novilase Laser Ablation Clinical Trial RequirementsDuring the Novilase clinical trial, you must meet the requirements for participation. If you're 18 or older, had a breast biopsy and received a clear diagnosis of fibroadenoma, ask your doctor or surgeon if it is 2 centimeters or smaller in diameter. If so, and the fibroadenoma can clearly be seen on an ultrasound, and it is half a centimeter away from your skin, you may qualify for the clinical trial. You must not be pregnant or breastfeeding, have a diagnosis of any type of breast cancer, or have had any potentially fatal condition in the last five years. If you have multiple fibroadenomas, that's no problem –- more than one can be treated during the procedure.
Getting Ready For Your Fibroadenoma Laser AblationA laser ablation of a breast fibroadenoma can be done in your surgeon's office or in the outpatient department of a surgery center. General anesthesia is not necessary. The procedure is done using local anesthesia, so you will be awake but will feel no pain during the ablation.
If you are feeling anxious and aren't sure if you can stay still, ask your doctor if you can take an oral anti-anxiety medication in advance.
You will disrobe from the waist up, and lie on an exam table for the procedure.
Finding The Target With UltrasoundYour fibroadenoma will be precisely located with an ultrasound scan. While using the ultrasound to find the lump, you may have to change position until the targeted tissue can be seen. This is necessary for accurate placement of the laser probe.
Your doctor will make sure you are in a comfortable position, and then local anesthesia will be injected to numb your breast. Some time will be allowed for the anesthesia to work.
Positioning The Laser and Temperature Probes
Once in position, a laser fiber will be threaded into the probe. Then a second, smaller probe will be inserted at the outer edge of your fibroadenoma. This is the temperature probe and it will be used to monitor the laser's heat.
Having Your Laser Ablation
As soon as the fibroadenoma has been destroyed, the probes are removed, and a small bandage is placed over the skin. If other fibroadenomas are being treated, the same procedure will be repeated for each lump.
Fast Recovery, Little Pain, Small ScarsPlan on going back to your normal activity within a few hours of the procedure. You may have some swelling and mild discomfort for 24-48 hours, which can be relieved with an ice pack or ibuprofen. There will be two eighth-inch scars on your breast.
Judy Gilberts, a patient who had a Novilase ablation, said, "I am very pleased with the fact that there is basically no scar at all! I was most pleased with how good I felt after the Novilase procedure."
Your breast will not change shape, as it would after a lumpectomy. It might be possible to feel a thick area of scar tissue at the ablation site, but that often fades over time. To make sure healing is going well, be sure to attend any follow-up appointments you may have.
Healing From WithinDr. Coleen Hagen, a general surgeon in Chicago, has done Novilase procedures as part of a clinical trial called American Breast Laser Ablation Therapy Evaluation (ABLATE). She says that after a laser has destroyed a fibroadenoma, healthy tissue will replace it. "It may take several months to completely heal but the patient may not be aware that healing is still going on inside the breast."
If you have a fibroadenoma larger than 2 centimeters, Dr. Hagen thinks laser ablation may still be part of the removal procedure. "I am looking into the possibility of removing part of these bigger fibroadenomas using a vacuum-assisted biopsy device and then ablating the remainder," she said. For many women, laser ablation may someday replace lumpectomy.
Lasers in Cancer Treatment: Questions and Answers. National Cancer Institute. Reviewed: 08/10/2004.
Personal correspondence with Dr. Colleen Hagen, December 11, 2009.
Personal correspondence with Judy Gilberts, December 15, 2009.