Primer

Introducing Cytotron

Cytotron, the latest non-invasive technology to treat patients with osteoarthritis of joints and terminal cancer, has recently got a shot in the arm by receiving EU certification, says Rita Dutta

At a time, when IGRT, IMRT, RapidArc and Cyberknife are breaking new grounds in treating cancer and knee replacement have become the commonest treatment, a new technology provides patients with wider choice for treatment and promises a better quality of life. Known as Cytotron, it is developed and patented by Bangaluru-based Centre for Advanced Research and Development (CARD), the research wing of Scalene Cybernetics Limited.

What makes this technology unique is that without killing diseased cells, Cytotron alters or regulates the cellular pathways and their protein synthesis pattern in achieving normal cellular function. Explains Dr Rajah Vijay Kumar, Chairman, Scalene Cybernetics Limited, who is a medical engineering specialist and inventor of Cytotron, "It is established that TMP is one of the known cellular signaling pathways. TMP pathways also regulate synthesis of various proteins at the appropriate time in the living cells. Many illnesses—like cancer, heart disease, degenerative disorders like cartilage loss and different kinds of inflammation — are also linked to disturbances in the protein transcription process. It was postulated in 1993, after assessing an earlier study in 1987-88, that if appropriate method can be developed to alter the TMP (in a controlled manner), most of these disorders that are protein-linked can be tackled."

The Genesis

The development of this technology started way back in 1987 with a dual gun device with just two RF guns. The next step was to extend the device to a six-gun device, for laboratory trials and then came a device for exposing the whole body. The first physical prototype of 360 degree rotational field exposure narrow focused 96 gun device and that was for the first time named Cytotron in 1998. After undergoing various lab tests, the first clinical trial phase I concluded at CARD with good results. The (phase II) was started in Bangaluru under an agreement with the Institute of Aerospace Medicine (IAM), Indian Air Force.

However, due to internal reasons in that institution and the premature retirement of the principle investigator appointed by IAM, the project was terminated with no conclusion and hence the trials had to restart all over again at CARD.

After various lab tests, safety standard tests and 'in silico' study, the project was re-started in 2004 after obtaining necessary approvals from the institutional ethics committee. As phase I trail of osteoarthritis had already concluded, it started with treating osteoarthritis of knee joints (phase II) with objective assessment, using MRI of the joints to measure cartilage thickness before and after treatment. In cancer treatment, the trial was done as a companionate trial on terminally ill cancer patients (phase I). " Phase II trial will soon be concluded. Preliminary reports indicate that freshly diagnosed tumors respond better to Cytotron treatment with fewer or no cancer spread, and better response to other treatments," says Dr Vijay.

Over the Years

"If we alter TMP pathways and cellular signaling in a controlled manner, most of these disorders that are protein-linked can be tackled" - Dr Rajah Vijay Kumar Chairman Organisation De Scalene Bangalore

"Patients have improved in pain score, total knee score, total functional score and range of movement, immediately after Cytotron treatment" - Dr Ranjit Kumar Principle Scientific Officer CARD

Besides CARD, many institutes are using Cytotron with success. Some of the institutes are Care Plus, Bangaluru; Sibia Medical Centre, Ludhiana; Safe Health, Hyderabad; Samarpan Hospital, Jam Nagar and Goutam Hospital, Kochi. Outside India, there are two centres in Malaysia CareNexus and Gleneagles Istan Medical Centre. There are two more Cytotron at Quress Liden in the Netherlands. The technicians operating Cytotron at all these centres are trained by CARD. CARD conducts certification programmes for technicians and medical professionals in operations and dosimetry.

Various centres prefer Cytotron as it requires no surgery- causes no skin scars, is painless, comfortable and safe, without any known side effects or complications. Cytotron requires no anaesthesia or blood transfusion. As it requires no hospital stay, patients can return to work daily after the treatment without having to take leave from work.

Cytotron Worldwide

Besides Indians, patients are trooping in from countries like Malaysia, Singapore, Netherland, Indonesia and the Middle East. The charges for treating arthritis patients ranges from Rs 90,000 to Rs 1,20,000. There are no charges for treating cancer patients at CARD, as trials are still on.

Cytotron recently received a big boost when it obtained the European Union (EU) Certification under Annex II, Section 3, of the Medical Devices Directive (MDD), 93/42/EEC as class IIA Medical Device. The CE certification, which is one of the most respected marks in the world, ensures adherence to the various consumer safety, health and environmental benchmarks of the EEA countries. "We have received requisitions to install Cytotron from Europe, Middle-East, Australia, Malaysia, Canada, New Zealand, South Africa and Mexico. We are expecting over 1,000 Cytotron machines to be installed around the globe by 2015, providing relief and better quality of life to patients," says an elated Dr Vijay.

How Cytotron Works?

It uses Rotational Field Quantum Nuclear Magnetic Resonance (RFQMR) technology to deliver complex time, amplitude and frequency modulated rotating quantum nuclear magnetic resonance beams to diseased tissue, using packet switching techniques. Cytotron produces poly-dimensional 'Rotating Target-Specific Modulated Radio Frequency Radiation' in the presence of high instantaneous magnetic field.

Cytotron looks like a modern whole-body MRI scanne, but has a bigger bore. The bore has a gantry that carries about 864 guns (older versions have 288 guns).

Each of the guns produce high instantaneous magnetic field and radio frequency. It also consists of a special near field antenna and parabolic reflectors to deliver these signals. These guns emit packets or quantum of programmed signals in time and space that are focused to the target, using laser guides. These emitted string of packets, which contain the dosimetry required for a specific medical condition is delivered by the antenna. The beams are then rotated in 360 degrees around the target. The patient is made to lie down on a traveling bed. When the bed travels into the bore of the Cytotron, the laser guides come on and the technician focuses the guns as per a pre-prepared template. The secondary dosimetry that is prepared by a trained doctor is initiated from the control room, and the Cytotron starts its job. After completing the assigned dose of radiation, the device automatically stops. The patient is then removed out of the bore.

Osteoarthritis of Knee

In a study to establish tissue regeneration, CARD used Cytotron on 380 knee joints with confirmed diagnosis of osteoarthritis, who were advised total knee replacement. The male to female ratio undergoing the treatment was 262:118 and their mean age was between 28 to 57. These patients were treated with Cytotron focused on both knees for 30 minutes every day for 21 consecutive days. They were evaluated before, and three month post treatment with the Knee Society Scoring System (KSSS), dynamometry and MRI evaluation of the knee joint using 3D FLASH sequence with water excitation. Says Dr Ranjit Kumar, Principle Scientific Officer, CARD, "There was highly significant improvement in pain score, total knee score, total functional score, range of movement and force of extension, immediately after the treatment. This improvement persisted when evaluation was repeated after three months."

Three-month post-treatment showed that there was a significant increase in Cartilage Thickness (CT) as established by MRI. In the studies done on osteoarthritis, 85 per cent of the patients treated during the phase II clinical trials were almost pain free with increased movement of their treated joints and could walk longer distance than what they could before the treatment, climb stairs and drive. Also, almost all the patients treated had statistically significant increase in cartilage thickness as indicated by MRI scans. It was also observed that a significant effect, that is the increase in cartilage thickness, is due to Cytotron exposure only. There were no gender difference or laterality effect observed in response to Cytotron treatment. More than 2,500 joints have been treated for osteoarthritis at various centres in India and abroad.

Cytotron for Cancer Patients

In a multi-centric trial, CARD is using Cytotron to treat patients with terminally ill cancer patients during the last four years. The purpose of the study is to arrest the growth of cancer cells, prevent further spread of the tumor and to provide the patients with better quality life. In case of terminal cancer patients, the success rate means a little different from that of osteoarthritis.

"Terminal cancer patients have a few weeks or months to live. So, in research involving terminal cancer patients, a one-year survival rate is taken. Out of the treated terminal cancer patients, the one-year survival rate was 52 per cent (including patients who died of heart attacks, infections kidney failure etc) while 92 per cent of the patients had improved quality of life, for whatever period they lived. All our research outcomes are audited by international third party audit and not the mere analysis of the project investigators," says Dr Vijay. The youngest patient treated on Cytotron so far, is two-and-half-year-old and the oldest is 92-year-old. At CARD, 140 terminal cancer patients have undergone treatment so far, through the Cytotron during clinical trials.

Limitations

Do all patients qualify for Cytotron treatment? "Other than some contraindications, there are absolutely no restrictions. The contraindications are to stop certain group of drugs, that use the same or similar cellular pathways as Cytotron, like calcium channel blockers, proton pump inhibiters, NSAIDs and alkaloids (also food containing alkaloids) for all regenerative treatments, but for treatment of degenerative treatment like cancer, they are to

stop drugs that act as calcium channel blockers and proton pump inhibitors," says Dr Vijay. Cytotron treatment is known to deplete all B-vitamins, and so, this is supplemented for all patients during the course of treatment.

Can a patient with cardiac stents, orthopaedic implants or pacemakers be treated with Cytotron? "None of the implants are a contraindication as long as they are MR compatible. Pacemakers are absolutely contraindicated, even if it is MR compatible. Pacemakers or any other radiosensitive implanted devices should not be allowed within 15 metres of the Cytotron," he says.

Radiation Worries

Is RFQMR harmful? "Radiations in the lower end of the spectrum are not harmful like the higher-end of the spectrum, where the ionising radiations can kill biological tissues. Low-end spectrum frequencies can cause minor physiological effects like depression or pain or some metabolic abnormalities, if uncontrolled," adds Dr Vijay.

With more centres evincing interest in using Cytotron and more patients benefitting from it, CARD is not only manufacturing more Cytotron equipment at its Bangalore campus, but is also promoting further research on using it for treating other illnesses.

rita.dutta@expressindia.com