Print Friendly

Extended anatomical range of Elekta’s Venezia encompasses cancer in cervix, parametrium and vagina

Embracing the insight of clinicians in the GYN GEC-ESTRO working group, Elekta has developed the Advanced Gynecological Applicator Venezia™. Venezia enables a highly versatile intracavitary/ interstitial approach to treating cervical cancer and extensions to the parametrium and vagina in advanced stages (IIB, IIIB, IVA, IIA2, and IIIA). Venezia can be seen as a hybrid brachytherapy applicator – combining the best characteristics of both ring and ovoid devices.

Venezia allows clinicians to treat advanced stages of cervical cancer with parametrial, uterine, vaginal or organ extensions, such as advanced stage IIB, IIIB, IVA, IIA2, IIIA, which previously required very specialized techniques such as freehand needle placement. Venezia allows treatment in a standardized way and enables various ways of reproducible interstitial needle placement.

For patients with locally advanced cervical cancer, chemoradiation is the standard treatment. The essential radiation component is a combination of external beam radiation therapy (EBRT) and high dose brachytherapy boost. Treating disease that has extended far into the parametrium and vagina has been challenging due to the limited reach of existing brachytherapy applicators. Guidelines recommend 3D image-guided adaptive brachytherapy – including interstitial brachytherapy if required – for locally advanced cervical cancer1-3. While interstitial needle insertion can optimize the dose distribution in advanced disease, for example, the procedure requires considerable skill and experience. Because of its design and function Venezia reduces the complexity of treating advanced stage cervical cancer. In addition, Venezia also is perfectly suited for treating cervical cancer in limited stages IB and IIA/B, in particular for reducing doses to adjacent organs at risk (rectum, bladder, vagina) in case of unfavorable topography.

The two lunar-shaped ovoids of Venezia form a ring that when clicked together provide the ease of insertion of a tandem and ovoid applicator in combination with the dose distribution afforded by a ring applicator. The ring creates a pear-shaped dose distribution (see below), a proven dosimetry shape that matches the cervix and endometrium.

Venezia: optimizing dose distribution with interstitial needlesVenezia facilitates creation of an optimized dose distribution. From the conventional point A (intracavitary brachytherapy), an extended dose pattern can be created by adding straight needles or straight plus oblique needles (interstitial brachytherapy), enabling clinicians to develop a conformal dose shape that also avoids overexposure of OARs. 3D imaging is essential for guiding needle placement. Images adapted from Kirisits C et al4

GYN GEC-ESTRO working group activities impact on Venezia development

Richard Pötter, MD, Professor and Head of the Department of Radiation Oncology at the Medical University of Vienna, is an internationally renowned expert in gynecological brachytherapy. Since 2004, he has been coordinator of the European network for 3D image-guided gynecological brachytherapy (GYN GEC-ESTRO), (co-)authoring the Gyn GEC-ESTRO Recommendations I and II in 2005 and 2006, originator of the international study EMBRACE (MRI-guided brachytherapy in locally advanced cervical cancer). He has been principal investigator of EMBRACE since 2008. He has coordinated the ICRU GEC- ESTRO report 89 together with Prof. Christian Kirisits, chief brachytherapy physicist in Vienna and at present GEC-ESTRO chairman.

Richard Pötter, MD, Professor and Head of the Department of Radiation Oncology at the Medical University of Vienna

Richard Pötter, MD, Professor and Head of the Department of Radiation Oncology at the Medical University of Vienna

Elekta solicited the guidance of Prof. Pötter and other members of GYN GEC-ESTRO (a.o., universities of Paris, Leuven, Utrecht, Nice, Aarhus, Ljubljana) in the development of Venezia. A GYN GEC-ESTRO workshop six years ago had confirmed the importance of straight needles and also – to treat advanced residual disease at the time of brachytherapy – the need for oblique needles, applied either freehand or as part of an in-house solution (see Growth of interstitial brachytherapy for cervical cancer).

“There is growing evidence that complementing straight needles with oblique needles is useful and beneficial in treating patients with advanced disease,” Prof. Pötter says. “GYN GEC-ESTRO centers began working on solutions to incorporate them in interstitial brachytherapy. In parallel, Elekta also began a project to develop a more versatile brachytherapy product for treating advanced cervical cancer and gained insight from members of GYN GEC-ESTRO. Both GYN GEC-ESTRO groups and Elekta essentially sought to combine the ovoid world with the ring world.”

The two-component design of the ovoid applicator has made this device easier to apply than the ring applicator, according to Prof. Pötter. The notable downside of the ring applicator is the difficulty in inserting the applicator as a unified element in certain patient groups (e.g., patients with smaller anatomy, such as Asian women).

In the design of Venezia, Elekta created two lunar-shaped ovoids that form a ring when clicked together.

“With Venezia, therefore, we should be able to realize the benefits of the ovoid’s simpler applicability and the ring applicator’s reproducible dose distribution,” he continues. “The ring shape places the dose on the lateral parts, sparing the anterior and posterior parts in a very reproducible, robust way. If you add needles through that ring you can sculpt the dose in a very predictable way into the proximal and distal parametria; the dose is distributed around the needle’s position. In principle, if you know where the disease is upfront, you can easily determine how many straight and oblique needles to use and in which location to put them in the applicator.

“Also, because the apertures for both straight and oblique needles are integrated in the ring,” Prof. Pötter adds “Venezia provides the option to use the applicator for intracavitary-only and combined intracavitary/interstitial treatments.”

Additional GYN GEC-ESTRO insight on the pattern of disease spread and response revealed a need to treat cervical cancer extension in the vagina as well, in particular in case of residual disease in the mid and lower vagina at the time of brachytherapy. To address this requirement in Venezia, Elekta included cylinder caps (inferior to the ring) that accommodate catheters for treating the vaginal wall.

A versatile needle template in Venezia also provides a perineal approach for reaching vaginal extensions. According to Prof. Pötter, the integrated needle template should encourage adoption of the applicator by more centers without requiring the considerable experience and expertise of free-hand needle placement. In addition, the predefined holes in the lunar-shaped ovoids and the needle depth insertion tool also contribute to a decreased need for free-hand needle placement.

“Interstitial brachytherapy can cause some circumspection among physicians, because the targets are deep in the pelvis,” he says. “Our approach historically has been a more template-like approach, in which you put the template – linked to the tandem – in the vagina. The interstitial ring is the template. Then, you can place the needles in a predictable way without having done hundreds of procedures. This means the ‘artistic’ approach of some very experienced clinicians is being replaced by a more systematic approach that can be learned by following certain guidelines. The result will be a more widespread procedure that is also safe and of high quality.”

Prof. Pötter sees in Venezia a solution that could become the definitive applicator for cervical cancer. “Elekta shared with GYN GEC-ESTRO centers the dream of a sort of universal applicator to treat cervical cancer and its extensions both in the parametria and vagina,” he says. “I think Venezia has the potential to become that type of applicator.”

  1. Haie-Meder C et al. Radiotherapy and Oncology 2005;74:235-45
  2. Viswanathan A et al. Brachytherapy 2012;11:47-52
  3. ICRU Report 89, Journal of the ICRU Volume 2013;13 (in press 2016)
  4. Kirisits C et al. Int J Radiat Oncol Biol Phys 2006;65:624-630
  5. Charra-Brunaud C et al. Radiotherapy and Oncology 2012; 103:305-313
  6. Pötter R et al. Radiotherapy and Oncology 2011;100:116-123
  7. Sturdza A et al. Radiother Oncol 2016 (in press)
  8. Fokdal et al. Radiother Oncol 2016 (in press)

DISCLAIMER:

Venezia is not available for sale or distribution in all markets and is not for sale in the United States and is pending 510k.

  1. Haie-Meder C et al. Radiotherapy and Oncology 2005;74:235-45
  2. Viswanathan A et al. Brachytherapy 2012;11:47-52
  3. ICRU Report 89, Journal of the ICRU Volume 2013;13 (in press 2016)
  4. Kirisits C et al. Int J Radiat Oncol Biol Phys 2006;65:624-630
  5. Charra-Brunaud C et al. Radiotherapy and Oncology 2012; 103:305-313
  6. Pötter R et al. Radiotherapy and Oncology 2011;100:116-123
  7. Sturdza A et al. Radiother Oncol 2016 (in press)
  8. Fokdal et al. Radiother Oncol 2016 (in press)

DISCLAIMER:

Advanced Gynecological Applicator Venezia™ is CE-approved and available for sales in the USA, but is not available in all markets.