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Open Access Study protocol

Monitoring of patients treated with particle therapy using positron-emission-tomography (PET): the MIRANDA study

Stephanie E Combs1*, Julia Bauer2, Daniel Unholtz2, Christopher Kurz2, Thomas Welzel1, Daniel Habermehl1, Thomas Haberer2, Jürgen Debus1 and Katia Parodi2

Author Affiliations

1 Department of Radiation Oncology, University Hospital of Heidelberg, INF 400, 69120 Heidelberg, Germany

2 Heidelberger Ionenstrahl Therapiezentrum (HIT), INF 450, 69120 Heidelberg, Germany

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BMC Cancer 2012, 12:133  doi:10.1186/1471-2407-12-133

Published: 3 April 2012

Abstract

Background

The purpose of this clinical study is to investigate the clinical feasibility and effectiveness of offline Positron-Emission-Tomography (PET) quality assurance for promoting the accuracy of proton and carbon ion beam therapy.

Methods/Design

A total of 240 patients will be recruited, evenly sampled among different analysis groups including tumors of the brain, skull base, head and neck region, upper gastrointestinal tract including the liver, lower gastrointestinal tract, prostate and pelvic region. From the comparison of the measured activity with the planned dose and its corresponding simulated activity distribution, conclusions on the delivered treatment will be inferred and, in case of significant deviations, correction strategies will be elaborated.

Discussion

The investigated patients are expected to benefit from this study, since in case of detected deviations between planned and actual treatment delivery a proper intervention (e.g., correction) could be performed in a subsequent irradiation fraction. In this way, an overall better treatment could be achieved than without any in-vivo verification. Moreover, site-specific patient-population information on the precision of the ion range at HIT might enable improvement of the CT-range calibration curve as well as safe reduction of the treatment margins to promote enhanced treatment plan conformality and dose escalation for full clinical exploitation of the promises of ion beam therapy.

Trial Registration

NCT01528670