Open Access Highly Accessed Study protocol

Multimodal hypoxia imaging and intensity modulated radiation therapy for unresectable non-small-cell lung cancer: the HIL trial

Vasileios Askoxylakis12*, Julien Dinkel3, Monika Eichinger3, Bram Stieltjes4, Gregor Sommer3, Ludwig G Strauss5, Antonia Dimitrakopoulou-Strauss5, Annette Kopp-Schneider6, Uwe Haberkorn7, Peter E Huber12, Marc Bischof1, Jürgen Debus12 and Christian Thieke12

Author Affiliations

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

2 Clinical Cooperation Unit Radiation Oncology, German Cancer Research Center (DKFZ), INF 280, 69120, Heidelberg, Germany

3 Department of Radiology, German Cancer Research Center (DKFZ), INF 280, 69120, Heidelberg, Germany

4 Quantitative Imaging-based Disease Characterization, German Cancer Research Center (DKFZ), INF 280, 69120, Heidelberg, Germany

5 Clinical Cooperation Unit Nuclear Medicine, German Cancer Research Center (DKFZ), INF 280, 69120, Heidelberg, Germany

6 Department for Biostatistics, German Cancer Research Center (DKFZ), INF 280, 69120, Heidelberg, Germany

7 Department of Nuclear Medicine, University of Heidelberg, INF 400, 69120, Heidelberg, Germany

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Radiation Oncology 2012, 7:157  doi:10.1186/1748-717X-7-157

Published: 14 September 2012

Abstract

Background

Radiotherapy, preferably combined with chemotherapy, is the treatment standard for locally advanced, unresectable non-small cell lung cancer (NSCLC). The tumor response to different therapy protocols is variable, with hypoxia known to be a major factor that negatively influences treatment effectiveness. Visualisation of tumor hypoxia prior to the use of modern radiation therapy strategies, such as intensity modulated radiation therapy (IMRT), might allow optimized dose applications to the target volume, leading to improvement of therapy outcome. 18 F-fluoromisonidazole dynamic positron emission tomography and computed tomography (18 F-FMISO dPET-CT) and functional magnetic resonance imaging (functional MRI) are attractive options for imaging tumor hypoxia.

Methods/design

The HIL trial is a single centre study combining multimodal hypoxia imaging with 18 F-FMISO dPET-CT and functional MRI, with intensity modulated radiation therapy (IMRT) in patients with inoperable stage III NSCLC. 15 patients will be recruited in the study. All patients undergo initial FDG PET-CT and serial 18 F-FMISO dPET-CT and functional MRI before treatment, at week 5 of radiotherapy and 6 weeks post treatment. Radiation therapy is performed as inversely planned IMRT based on 4D-CT.

Discussion

Primary objectives of the trial are to characterize the correlation of 18 F-FMISO dPET-CT and functional MRI for tumor hypoxia imaging in NSCLC and evaluate possible effects of radiation therapy on tumor re-oxygenation. Further objectives include the generation of data regarding the prognostic value of 18 F-FMISO dPET-CT and functional MRI for locoregional control, progression free survival and overall survival of NSCLC treated with IMRT, which will form the basis for larger clinical trials focusing on possible interactions between tumor oxygenation and radiotherapy outcome.

Trial registration

The ClinicalTrials.gov protocol ID is NCT01617980

Keywords:
Hypoxia; Imaging; Radiotherapy; Non-small-cell lung cancer