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Clinical Activities

The fourth group gathers 8 clinical centres (medical physicists and  radio-oncologists).

This group is in charge of the validation of the main products developed in the technical groups of MAESTRO.

To this aim, a three steps procedure is followed during the 5 years of the project :

Requirements

During the first four months of the project, a document has been written to specify to the research centres the from a clinical point of view for the tools they are developing.

This document has been written by medical physicists and radio-oncologists in collaboration with the developers.

The requirements gather the characteristics that each tool developed within MAESTRO should ideally reach before the end of the project (may 2009).

Protocols

Then, before the end of the first year of the project (May 2005), have also been written.

Different protocols have been written regarding the characteristics of the tools. One protocol deals with the theme of patient repositioning and organ tracking ; another protocol deals with radiation therapy software and a third one has been written for the dose sensors.

These protocols define the exact procedure to be followed when the tools developed inside the technical groups are tested in a clinical centre. This way, all the tools could be tested in the same conditions in several clinical centres.

These protocols keep on evolving depending on the improvements brought to the tool during the development phase.

Clinical validation

This point consists also of three steps:

a.  During the development phase of the tools, tests are continuously performed by the developers. These tests can be performed inside the research centres and / or in collaboration with clinical centres.

b.     Once a tool is available in a functional version, a prototype is sent to one clinical partner to be tested in clinical environment. These tests are performed following the protocols described in point 2 using phantoms if necessary (figure 1). No tests are performed with patients at this step.

The results of these tests are given to the developers who can modify or improve some characteristics of the tool.

This first phase of clinical tests is going on until the tool is considered as a “final product” that can be used in clinics.

              c.      Once the “final product” is available, it is sent to four other clinical centres for a final clinical validation.

Tests can be performed during the treatment of the patient, but without any interaction on the treatment delivery.

To end, when a fully satisfactory version of a tool, according to the MAESTRO criteria, is available, the MAESTRO label is delivered to the product.

Standards phantoms

 

Figure 1. Liqui-PhilTM Head Phantom.
(Phantom Laboratory, www.phantomlab.com)

 

Figure 2. Multi-Purpose Body Phantom.
(QuasarTM, www.QUASARphantoms.com)

 

Figure 3. The Rando Alderson anthropomorphic humanoid phantom.
(RANDO
Ň Phantom, Phantom Laboratory,
www.phantomlab.com)

News phantoms developed by the University of Florence

Design and implementation of a water phantom for IMRT, arc therapy and tomotherapy dose distribution measurement, in press on Medical Physics.

 A new phantom for arc therapy, intensity-modulated radiation therapy (IMRT) and tomotherapy dose distribution measurement and pre-treatment verification (Italian patent application n° FI2006A000167) has been designed and developed. The innovation of the presented phantom is the use of water as the tissue equivalent material together with a technical solution specifically designed to support radiographic or radiochromic films and ionization chambers in the desired position.

The phantom is a Plexiglas container whose shape and dimensions offer the possibility to simulate a human torso or abdomen which can be filled with water by opening the upper cover. On the internal side of the cover a set of carbon pipes supports films in the desired coronal, axial or sagittal planes. At one of the two ends of the phantom, an ionization chamber can be positioned parallel to the rotation axis of the accelerator gantry in all the possible positions inside a 20 cm diameter cylinder,  for film calibration purposes.

Inhomogeneities can be inserted into the phantom using the same carbon pipes and plastic sheets used to support films.

Figure 4. The phantom holding a laminated radiographic film.

Figure 5. The phantom holding a radiochromic film.

Figure 6. An example of vertebra shaped inserts of bone equivalent material.

For more information, please contact one of the following persons from the Department of Clinical Physiopathology at the University of Florence (Italy):
    - Professor Marta Bucciolini : marta@dfc.unifi.it or
    - Uuia Marrazzo or
    - Stefania Pallotta : stefania.pallotta@unifi.it