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Cryoablation

What is Cryoablation?

Part of a medical subspecialty called interventional radiology, cryoablation literally freezes tumors to death with argon gas, delivered through small, ultrasound-guided probes. One of the most promising applications is for invasive ductal carcinoma—in lay terms, breast cancer in the form of a solid, distinct, malignant breast tumor in the lining of a milk duct.

Invasive ductal carcinoma is the most common form of breast cancer. Although cryoablation is not yet in general clinical use for treating breast cancer, a past clinical trial has demonstrated its effectiveness in Stage I breast cancer patients with a single, small tumor that is solid, round, and distinct, and that has not spread to other areas.

Fibroadenomas are the most common type of breast tumor (lump). They are solid (not fluid-filled) masses, have clearly-defined edges and are typically round or oval in shape. Fibroadenomas are benign, which means they are not cancerous, and do not turn into cancer. They may increase in size with time, particularly with hormonal changes. Some women find these lumps or masses uncomfortable and bothersome, and may have associated pain or tenderness. Cryoablation is an alternative to surgery to destroy these fibroadenomas (lumps) and ease any discomfort or pain immediately.

What to Expect During the Procedure?

Performed under local anesthesia, the cryoablation procedure is virtually painless and takes approximately 20 minutes in RMI’s outpatient facility on Lennon Road. A probe about the size of a pencil will be inserted into the middle of the tumor, guided by ultrasound. Patients should be able to resume a normal routine almost immediately following this outpatient procedure.

Clinical Trial of Cryoablation

Who Can Participate?

Patients diagnosed with Stage I invasive ductal breast carcinoma, with a single, distinct tumor that is 15 mm in diameter or smaller, may be eligible. Diagnosis will be verified by a needle biopsy at RMI. Patients must not be pregnant. Other restrictions, such as past history with certain types of biopsies, may exclude some patients. All criteria will be reviewed in detail with patients interested in participating.

Many candidates for the trial will be identified during the process of diagnosis at RMI of early-stage breast cancer cases during routine breast imaging tests. But patients who believe they may be candidates can ask their doctors to contact RMI.

Will Participating in the Trial Affect Patients’ Prognosis?

The cryoablation procedure will not adversely affect the positive prognosis of patients with Stage I invasive ductal breast carcinoma. After the cryoablation, participants will not receive a traditional lumpectomy, which is the current treatment of choice.

Standard followup diagnostic tests will be conducted. Depending on the individual patient’s case, this could include anti-hormone therapy and radiation therapy. The followup MRI is related to another goal of the clinical trial: investigating whether an MRI is as effective as a pathological examination in verifying that the cancer has been destroyed.

Are There Side Effects?

Participants may experience some side effects from the cryoablation procedure, and should discuss those possibilities with their medical team before finalizing their decision to participate.

Is There a Cost to Participate?

There is no cost to patients or their insurance plans to participate in the trial. Costs other tests and treatments that patients would otherwise receive remain the responsibility of the patients or their insurance companies.

What are the Deadlines?

The study is an “open trial,” meaning that there is no set end date or limitation on the number of patients.

Resources

What is Cryoablation?

Part of a medical subspecialty called interventional radiology, cryoablation literally freezes tumors to death with argon gas, delivered through small, ultrasound-guided probes. One of the most promising applications is for invasive ductal carcinoma—in lay terms, breast cancer in the form of a solid, distinct, malignant breast tumor in the lining of a milk duct.

Invasive ductal carcinoma is the most common form of breast cancer. Although cryoablation is not yet in general clinical use for treating breast cancer, a past clinical trial has demonstrated its effectiveness in Stage I breast cancer patients with a single, small tumor that is solid, round, and distinct, and that has not spread to other areas.

Fibroadenomas are the most common type of breast tumor (lump). They are solid (not fluid-filled) masses, have clearly-defined edges and are typically round or oval in shape. Fibroadenomas are benign, which means they are not cancerous, and do not turn into cancer. They may increase in size with time, particularly with hormonal changes. Some women find these lumps or masses uncomfortable and bothersome, and may have associated pain or tenderness. Cryoablation is an alternative to surgery to destroy these fibroadenomas (lumps) and ease any discomfort or pain immediately.

What to Expect During the Procedure?

Performed under local anesthesia, the cryoablation procedure is virtually painless and takes approximately 20 minutes in RMI’s outpatient facility on Lennon Road. A probe about the size of a pencil will be inserted into the middle of the tumor, guided by ultrasound. Patients should be able to resume a normal routine almost immediately following this outpatient procedure.

Clinical Trial of Cryoablation

Who Can Participate?

Patients diagnosed with Stage I invasive ductal breast carcinoma, with a single, distinct tumor that is 15 mm in diameter or smaller, may be eligible. Diagnosis will be verified by a needle biopsy at RMI. Patients must not be pregnant. Other restrictions, such as past history with certain types of biopsies, may exclude some patients. All criteria will be reviewed in detail with patients interested in participating.

Many candidates for the trial will be identified during the process of diagnosis at RMI of early-stage breast cancer cases during routine breast imaging tests. But patients who believe they may be candidates can ask their doctors to contact RMI.

Will Participating in the Trial Affect Patients’ Prognosis?

The cryoablation procedure will not adversely affect the positive prognosis of patients with Stage I invasive ductal breast carcinoma. After the cryoablation, participants will not receive a traditional lumpectomy, which is the current treatment of choice.

Standard followup diagnostic tests will be conducted. Depending on the individual patient’s case, this could include anti-hormone therapy and radiation therapy. The followup MRI is related to another goal of the clinical trial: investigating whether an MRI is as effective as a pathological examination in verifying that the cancer has been destroyed.

Are There Side Effects?

Participants may experience some side effects from the cryoablation procedure, and should discuss those possibilities with their medical team before finalizing their decision to participate.

Is There a Cost to Participate?

There is no cost to patients or their insurance plans to participate in the trial. Costs other tests and treatments that patients would otherwise receive remain the responsibility of the patients or their insurance companies.

What are the Deadlines?

The study is an “open trial,” meaning that there is no set end date or limitation on the number of patients.

Resources
 

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