James Suliburk, MD, chief of endocrine surgery at Baylor College of Medicine, talks about a new way to sample tissue inside the body to determine if it is cancerous during an operation.
Why don’t you describe to us how the cancer pen and works and why it’s an improvement over previous technology?
JAMES SULIBURK: The mass spec pen, or as it’s known as the cancer pen, is a significant improvement over current standard of care technology in assessing tissue for both cancer as well as tissue type. For the last hundred years in surgery and in pathology we’ve had to cut tissue out of the body and then process it to be examined on a microscope. That hasn’t changed throughout the course of all the developments of modern medicine. Our new pen, the “Mass Spec Pen”, or “cancer pen,” is able to sample that tissue as it sits in the human body and to determine whether or not a cancer exists in that tissue as we operate. This is extremely helpful for surgeons. Number one, it allows us to have improved accuracy in diagnosis. Number two, it allows us to have improved precision in the operation. And number three, it improves our speed of the operation. So anytime we can offer a faster more precise and more accurate surgery, the patient’s going to win.
Who invented the pen? How long has it been around? And how much time and effort will it save you and benefit the patient?
JAMES SULIBURK: The mass spec pen or the cancer pen was developed by a collaborative group of researchers from both Baylor College of Medicine as well as the University of Texas at Austin. We involved experts including surgeons, research engineers, research chemists and pathologists from both institutions. It’s really an all-star team of scientists and clinicians who’ve come together to develop the pen. Our analysis of the information that we obtain from the pen is also facilitated by a researcher at Stanford University.
How long has it been around and how much time and effort will it save you?
JAMES SULIBURK: We’ve spent around three years developing the pen so far. Our initial preliminary results show that it can save us up to 35 minutes per surgery per sample as we operate. This translates into a significant reduction in the time spent in the operating room, a significant reduction in the time for which the patient is exposed to general anesthetic. These all translate to improved outcomes in terms of lower incidences of surgical site infection and again higher precision with the surgery. We anticipate that it will result in a clinically significant improvement in margins of resection for the surgery.
How was it first determined that this could detect cancer in real time during surgeries?
JAMES SULIBURK: We initially started our work with the mass spec pen, or the cancer pen, by performing animal studies using some mouse models of cancer. These studies were able to demonstrate that the pen was highly accurate in detecting different types of tumor within different types of tissue that we operate on. We developed an initial pilot project at Baylor St. Luke’s Medical Center and Baylor College of Medicine using the pen testing its ability to detect cancer in the thyroid, the para thyroid, lymph nodes, breast surgery, pancreas surgery, liver surgery, and even stomach surgery. It’s able to be used in a variety of different tissue types. Our most promising work thus far to date has been in breast cancer and thyroid cancer where we are able to distinguish normal thyroid from cancerous thyroid. Furthermore, we’re actually able to do this not just on the tissue as we operate but we’re able to even do this on biopsies that are obtained as an outpatient when we’re making an initial diagnosis. We’re very excited about this.
A little bit about the patient that we’re going to interview and what was the situation there?
0:05:42:>>JAMES SULIBURK: He had a thyroid nodule which is very common and more than 50 percent of the population has thyroid nodules. Fortunately, only about 5 percent of those thyroid nodules end up needing surgery, and his is one particular case. His biopsy of the nodule showed an indeterminate biopsy which then meant that he had to have surgery to obtain a diagnosis. This is where a cancer pen comes into play. We’re hoping that we increase the diagnostic accuracy of these thyroid biopsies that are obtained. Some of these thyroid biopsies that are obtained have indeterminate results, meaning that the results indicate there is somewhere between a 5 and 30% chance of cancer. In his particular case, we’re using standard of care treatment and the standard of care biopsy was an indeterminate result. That means he had somewhere between a five and a 30 percent risk of having a malignancy in the thyroid nodule which resulted in him having to come to surgery and have that side of his thyroid removed in order to do additional diagnostic testing on the thyroid to obtain his final diagnosis of cancer or benign tissue. Fortunately, in his case we were able to clear all the disease and he now has no evidence of cancer whatsoever.
In a nutshell, how is this pan a game changer in what we’ve done in previous times?
JAMES SULIBURK: The mass spec pen is a game changer in terms of revolutionizing technology as we use it both to diagnose patients from their biopsies as well as to ensure that we’ve cleared all cancerous tissue during the operation. It allows us to perform faster, more precise and more accurate surgery. It’s a product of collaboration amongst world leading scientists and clinicians at multiple institutions. It is a next generation technology that we’re bringing to our patients here today.
And does it save lives?
JAMES SULIBURK: When patients come to me for surgery and they have a possibility of having a cancer, we want to be able to use the cancer pen on those patients to improve our technology, to improve our results for future patients. We’re still in preclinical research phase, but we’re just one or two years away from actually having this in full clinical use. If a patient comes to me needing thyroid surgery with the question of having a malignancy in their thyroid, we’re going to work them up per standard of care that means getting a biopsy and then treating them with surgery based on those biopsy results. During the surgery, we will use the cancer pen or the mass spec pen to sample the cells of the thyroid that we’re going to take out as part of their normal clinical treatment. That information is then pulled into our database. After the surgery is all over, we correlate the information obtained from the cancer pen with the final diagnosis for the patient. So far, our cancer pen is providing more than a 90 percent accuracy in diagnosis. So, we’re rapidly approaching full standard of care for clinical use of this pen.
So, in the future they would come in and what?
JAMES SULIBURK: In the future, patients will still have to have a biopsy, but will be able to use our pen to increase the accuracy of those biopsy results. Currently around 20 percent of patients who undergo a biopsy of the thyroid will have an indeterminate result. We want to bring that number down to less than 5 percent. That results in us being able to keep patients out of the operating room preventing them from being exposed to unnecessary risk of surgery and saving costs to the healthcare system. In addition to this, the mass spec pen will allow us to provide state of the art diagnoses to patients with growths that may be cancerous.
So, right now those 20 percent – if you have an indeterminate, what happens?
JAMES SULIBURK: If you’re one of the 20 percent of patients who has an indeterminate biopsy result after your evaluation for a thyroid nodule, we will then review that information and determine if genetic testing of that thyroid nodule biopsy will be of any value. If the genetic analysis will not change the managment, then the patient will need to undergo surgery. If there is a role for genetic testing to be done as an option to keep the patient out of the operating room, once the genetic testing is performed, many times those results will still say it’s an indeterminate result and the patient will still need surgery. Now in the future when we use our cancer pen technology, we will be able to reduce that 20 percent indeterminate biopsy result down to less than five percent, thereby offering patients a certain diagnosis in a very rapid manner in real time and keeping patients out of the operating room who have otherwise benign disease and no need for surgery.
Is there anything I left out or did not ask you?
JAMES SULIBURK: I think we should talk about the speed of it. The cancer pen actually allows us to get diagnoses in real time. We apply the pen to the cells of the tissue that is suspected of having cancer. We use a machine learning algorithm to then process data, and within seconds we’re able to have a diagnosis of whether there are cancer cells present or not in that tissue type. Diagnosis within seconds would also be revolutionary in this field. We hope that intra operative use of the mass spec pen, or the cancer pen, will allow us to reduce operating time significantly. Many times, it can take between 30 minutes to 1 hour to obtain frozen section margin information for each segment analyzed so that the surgeons know all the tissue that was cancerous has been cleared of the field. Every 30 minutes, the patient is on the operating room table exposed to general anesthesia and exposed to the environment increases their risk of surgical site infection and decreases their quality outcomes. We expect that the mass spec pen will be able to not only improve our accuracy of diagnosis but overall reduce our operative time and improve patient outcome.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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If you would like more information, please contact:
Dipali Pathak, Assistant Director of Communications
Baylor College of Medicine
713-798-6826
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