Novalis® - Frequently Asked Questions

1. What are stereotactic radiosurgery and fractionated stereotactic radiotherapy?
2. What is Novalis® Shaped Beam Surgery?
3. Why would I want to choose Novalis for treatment?
4. Who is a candidate for treatment?
5. What is a typical treatment day like?
6. What can I do on treatment day?
7. What are the side effects and risks of stereotactic radiosurgery/fractionated stereotactic radiotherapy?
8. How do I get more information about Novalis Shaped Beam Surgery?

1. What are stereotactic radiosurgery and fractionated stereotactic radiotherapy?

Stereotactic Radiosurgery/Radiotherapy is a non-invasive treatment alternative for treating lesions and malformations of the brain, head & neck, spine, liver, lung and prostate.Stereotactic radiosurgery is performed in a single session. Fractionated stereotactic radiotherapy is performed in multiple sessions.

Stereotactic radiosurgery delivers higher doses of radiation. Due to the high dose that is used, it is crucial that the dose of radiation be delivered only to tumorous tissue. The ionizing radiation is used to shrink or control tumor growth by killing tumor cells or interfering with their ability to divide. Although the procedure is called surgery, there is no actual incision and the procedure is performed on an outpatient basis.

Due to the inherent advantage of radiosurgery over open surgery, especially in the treatment of benign intra-cranial mass lesions, arteriovenous malformations (AVMs), and metastatic brain tumors, the use of stereotactic radiosurgery is increasing at an accelerated rate throughout the world. Over the last decade, there have been remarkable advances in this treatment modality due to continuous improvements in medical imaging, high-speed computer technology and advanced delivery devices. [Top]

2. What is Novalis Shaped Beam Surgery?

Throughout the evolution of radiosurgery systems, the primary goal has been to refine delivery of the desired dose of radiation only to the affected tissue. Now, the possibilities of radiosurgery have reached a new peak with the pioneering technology of Novalis Shaped Beam Surgery. By shaping the radiation beam exactly to the shape of the tumor, Novalis Shaped Beam Surgery delivers a homogeneous dose of radiation only to the tumor. Dose to healthy tissues and organs is greatly minimized. The treatment beam is continuously adjusted to match the size and shape of the tumor from numerous angles, ensuring that the tumor receives the full prescription dose while healthy brain tissue is protected. [Top]

3. Why would I want to choose Novalis for treatment?

• Increased Precision and Sparing of Healthy Tissue
  Equipped with highly sophisticated computer-based imaging techniques, Novalis delivers the radiation beam with incredible accuracy, while greatly reducing the dose of radiation to the surrounding healthy tissue. Novalis treats cranial and extra cranial lesions, which were at one point in time considered inoperable due to their proximity to critical structures. It may be a treatment option for patients whose doctors cannot perform traditional surgery due to the increased risk of harming critical structures inside the brain or body. Novalis is also increasingly a treatment of choice for patients with multiple tumors.
   
• Beam Shaping
  The Novalis radiation treatment beam is continuously adjusted to match the size and shape of the tumor from numerous angles, ensuring that the tumor receives the full prescription dose while healthy tissue is protected.
   
• Application of Multiple or "Fractionated" Doses
  With Novalis, treatment can be delivered in fractionated dose treatments. Clinical results have demonstrated that delivering multiple or "fractionated" doses provides a therapeutic advantage in treating tumors that are close to or include cranial nerves, critical regions of the brain, or sensitive organs. This opens up the possibility to treat lesions, which could not be treated by single dose radiosurgery.
   
• Non-Invasive Surgery
  Again, although radiosurgery is called surgery, no incisions are made and invasive surgery is not necessary. Stereotactic radiosurgery itself is painless and no anesthesia is required for the treatment. This procedure decreases the patient's risk of suffering side effects such as infections, hemorrhaging, or other complications characteristic of invasive surgery or the risks generally associated with anesthesia.
   
• Outpatient Procedure
  Radiosurgery treatment with Novalis Shaped Beam Surgery is typically performed on an outpatient basis. The patient arrives in the morning and returns home in the afternoon, resuming his/her normal routine immediately following the therapy. [Top]

4. Who is a candidate for treatment?

Your physician will determine if you are a candidate for this non-invasive surgical procedure. The size of the tumor, location, it's growth pattern, and your medical history will determine if radiosurgery/radiotherapy is the appropriate kind of treatment for you. Some of the clinical indications that can be treated with Novalis include:

Primary brain tumors

• gliomas (astrocytomas, glioblastomas, oligodendrogliomas, ependymomas)
• acoustic neuromas / acoustic schwannomas
• pituitary tumors
• meningiomas
• chordomas and chondrosarcomas
• brain metastases

Non-cancerous conditions

• arteriovenous malformations (AVMs)
• cavernous malformations
• trigeminal neuralgia
• intractable seizures
• Parkinson's disease

Other cancerous lesions

• Spine, liver, lung and prostate lesions

More About Primary Brain Tumors and Treatments

Gliomas
Glioblastoma multiforme (gbm) - one of the most common primary intra-cranial tumors is traditionally treated with a combination of surgery, radiation, and chemotherapy. Stereotactic radiosurgery may be considered as a non-invasive treatment option especially for patients with radiographically distinct, and focally recurrent gbm. Used alone or in conjunction with conventional surgery, Novalis Shaped Beam Surgery can help provide a better quality of life and longer survival for patients with gbm. The majority of malignant brain tumors are relatively radio-resistant and the dose of conventional radiotherapy that can be locally delivered is limited by the tolerance of the surrounding healthy brain tissue. By using stereotactic radiosurgery, higher doses of focused radiation can be delivered.

Acoustic tumors
Acoustic neuromas and acoustic schwannomas are benign lesions arising from the eighth cranial nerve. They are most often treated by surgical resection. Stereotactic radiosurgery or fractionated stereotactic radiotherapy can be a non-invasive treatment alternative and has been proven very effective in tumor control, as well as in the preservation of facial function and hearing.

Pituitary tumors
Stereotactic radiosurgery or fractionated stereotactic radiotherapy is now an alternative to surgical resection and wide-field irradiation in the management of pituitary tumors. The use of more precise dosage confinement decreases the recognized risk of temporal lobe damage. Currently, stereotactic radiosurgery is reserved for lesions that are located in the sella turcica and are further than 5 mm to the optic apparatus. Further radiation for patients with recurrent tumors is possible.

Meningiomas
The treatment of meningiomas is mostly done by surgical resection, although the management is related to tumor location. The data already available on the use of stereotactic radiosurgery in patients with meningiomas suggests that this procedure may be valuable for patients who would not be expected to tolerate surgical resection due to advanced age, underlying medical comorbidities, or an inaccessible or high-risk tumor location. It has been shown that stereotactic radiosurgery is relatively safe and effective, as either a primary or an adjuvant treatment.

Chordomas, chondrosarcoma
The standard treatment for chordomas and chondrosarcomas of the skull - open resection and fractionated radiation therapy - is often relatively ineffective. Recurrence and development of new neurological deficits have been reported in patients with these types of lesions. Your physician will determine whether Novalis is a favorable option for your condition.

Brain metastases
Intra-cranial brain metastases are typically well localized, but often have multiple lesions making removal untenable or unachievable. Novalis Shaped Beam Surgery is often a preferred option in such cases. [Top]

5. What is a typical treatment day like?

For treatment of cranial tumors and lesions:

Step 1: Fitting of the Headring/Mask Attachment and Diagnostic Imaging
In preparation for your stereotactic radiosurgery procedure, the neurosurgeon may fix a metal headring on your head. During the fitting, local anesthesia will be used to avoid discomfort. The headring may be necessary for proper localization of your brain tumor.

If you are undergoing fractionated stereotactic radiotherapy, a facemask will be used instead of the metal head ring. Its use is painless.

Step 2: Diagnostic Imaging
Next, a Computed Tomography (CT) scan will be taken. During the diagnostic imaging the metal headring or the facemask will be worn. Other necessary scans like Magnetic Resonance Imaging (MRI) and/or PET/SPECT can be taken on the day before the Novalis treatment. No metal headring has to be worn for those procedures.

Step 3: Image Transfer and Planning
The radiosurgery team gathers information from the scans and enters it into the Novalis software program to determine the precise target position, dosage and configuration of radiation beams. While the treatment is being planned, you will be free to relax in the waiting area. It may be a good idea to bring a book or some other way to pass the time. Once the customized treatment plan has been completed, you will be positioned comfortably on a specially designed couch. Next, a series of carefully controlled quality checks using Novalis instruments are performed prior to treatment in order to assure that the radiation beams will be guided precisely to the chosen target position.

Step 4: Treatment
The actual treatment session typically takes about 30 - 45 minutes. This involves the movement of the Novalis machine around your head or body as the focused beams converge on the target. Multiple radiation beams radiate the tumor from different angles. The invisible radiation is not felt at all.

For treatment of tumors located within the body:

Depending on your indication and individual treatment plan, the procedures may vary from case to case. The radiation oncologist will discuss your individual treatment schedule with you. [Top]

6. What can I do on treatment day?

You might want to dress comfortably and bring a bottle of water and some straws. Driving is not recommended. It is advisable to arrange for someone to accompany you to the treatment and be available to transport you home. [Top]

7. What are the side effects and risks of stereotactic radiosurgery/fractionated stereotactic radiotherapy?

Side effects that you might experience immediately following treatment include headache and dizziness. Your doctor will discuss specific side effects with you, which may occur depending on your overall treatment plan. [Top]

8. How do I get more information about Novalis Shaped Beam Surgery?

Please contact us for further information: email shapedbeam@mrccnet.com or call 877-368-2334. [Top]