Practical implementation of a multi-center trial in a non-academic hospital -Possible role of RTT s -
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1 Practical implementation of a multi-center trial in a non-academic hospital -Possible role of RTT s - Emile Janssen, Mariska de Smet, Paul van Haaren, Maarten van Lieshout, Anke Habraken, Fanny van Aarle, Roxane Moonen, Antoinette van Mill, Dennis Hellegers, Helma van Berkum, Cindy Maandag, José Belderbos* and Katrien de Jaeger Catharina Hospital, Eindhoven, The Netherlands *Netherlands Cancer Institute, Amsterdam, The Netherlands EORTC-ROG-RTT congress Paris, Content - Introduction: hippocampal avoidance PCI trial - Implementation at Catharina hospital -Neurocognitive testing (NCT) by RTT s -MRI-protocol - Treatment planning and radiation technique
2 Prophylactic Cranial Irradiation - Whole brain irradiation to prevent brain metastases: - significant reduction of brain mets in patients with SCLC - neuro cognitive toxicity Prophylactic Cranial Irradiation - Whole brain irradiation to prevent brain metastases: - significant reduction of brain mets in patients with SCLC - neuro cognitive toxicity hippocampus avoiding PCI
3 Hippocampus (left and right) Possible tolerance dose of hippocampus 10 Gy Hippocampal avoidance PCI Multicentre trial nr. NCT , Inclusion: - SCLC, no metastasis - Good treatment response PCI R PCI HA-PCI
4 Study objectives and endpoints Primary objective: - to reduce memory function loss with hippocampal avoidance PCI (HA-PCI) compared to full PCI in SCLC pts Secondary objectives: - to assess early and late neurotoxicity and QoL - to assess structural and functional brain abnormalities on MRI - to assess the incidence and location of brain metastases - Influence on PFS and OS Study Flow Chart HA-PCI Baseline tests: -NCT -QoL -MRI Randomization 10 x 250 cgy PCI 10 x 250 cgy 4 months after PCI: - NCT - QoL - MRI 8 months after PCI: - NCT - QoL 12 months after PCI: - NCT - QoL - MRI 18 & 24 months after PCI: - NCT -QoL
5 Implementation in CZE time table May 2013: Feasibility study with regard to MRI scans November 2013: METC application for local advice Feb 2014: visit the Netherlands Cancer Institute Feb 2014: training RTT s for taking neurocognitive tests Feb 2014: QA MRI & setup MRI protocol with radiology department Feb-April 2014: develop HA-PCI radiation technique April 2014: start study, feedback on first 3 patients Duration of patient inclusion period of the study is estimated to be 4 years Implementation in CZE time table May 2013: Feasibility study with regard to MRI scans November 2013: METC application for local advice Feb 2014: visit the Netherlands Cancer Institute Feb 2014: training RTT s for taking neurocognitive tests Feb 2014: QA MRI & setup MRI protocol with radiology department Feb-April 2014: develop HA-PCI radiation technique April 2014: start study, feedback on first 3 patients Duration of patient inclusion period of the study is estimated to be 4 years
6 Neuro-cognitivetesting by RTT s Training: - 3 RTT s and a research-nurse were recruited for performing the neuro-cognitive tests - Trained by Sanne Schagen, neuro-psychologist at NKI - Further training & practice within the group Study: - 1st time: observed by another group member - Patients have each time the same RTT who performs the tests - Warm reception/empathy towards patient is very important - Record some parts of the test on a voicerecorder - Results are not directly discussed with the patients Neuro-cognitive testing by RTT s Hopkins Verbal Learning Test
7 Neuro-cognitive testing by RTT s Trail making part 1 Neuro-cognitive testing by RTT s Trail making part
8 Neuro-cognitive testing by RTT s Trail making part 1 Neuro-cognitive testing by RTT s Trail making part
9 Neuro-cognitive testing by RTT s Trail making part 1 Neuro-cognitive testing by RTT s Trail making part
10 Neuro-cognitive testing by RTT s Trail making part 2 Neuro-cognitive testing by RTT s Trail making part
11 Neuro-cognitive testing by RTT s Trail making part 2 Neuro-cognitive testing by RTT s WAIS digit span
12 Neuro-cognitive testing by RTT s WAIS digit symbol Neuro-cognitive testing by RTT s Controlled Oral Word Association
13 Neuro-cognitive testing by RTT s Grooved Pegboard QoL examination by RTT s Questionnaires: - quality of life - physical complaints - perception of their situation and future - health score from 1-10 Clinical assessment of motor function and balance: - interview - examination of tandem gait (walk 10 steps heel to toe)
14 Implementation in CZE time table May 2013: Feasibility study with regard to MRI scans November 2013: METC application for local advice Feb 2014: visit the Netherlands Cancer Institute Feb 2014: training RTT s for taking neurocognitive tests Feb 2014: QA MRI & setup MRI protocol with radiology department Feb-April 2014: develop HA-PCI radiation technique April 2014: start study, feedback on first 3 patients Duration of patient inclusion period of the study is estimated to be 4 years QA MRI By Stephanie Bogaert and Patricia Clement of Ghent University Hospital 2x/yr with ACR phantom and two (same) volunteers - Geometric accuracy - Slice thickness accuracy - Slice position accuracy - Image intensity uniformity - Percent signal hosting - Low contrast detectability - Signal to noise ratio - Consistency patient scan results
15 MRI protocol HA-PCI 3T MRI Naam Type Oriëntatie Survey MPRAGE_adni fmri No extra slices MST SAG TRA B0-fieldmap VEN_BOLD_SWI 3D_FLAIR Whole cranium No extra slices TRA1 TRA SAG ; music off, wakefullness level notation contrastinjection 0,2 ml/kg dotarem T2FFE T1_SE_tra T1_SE_cor 4 min post injection TRA2 TRA2 COR Angulation corpus callosum Angulation corpus callosum Vertical on TRA after gado Total scan time = 50 min! 29 MRI protocol hippocampus delineation for RT planning HA-PCI 3T MRI Naam Type Oriëntatie Survey MPRAGE_adni fmri No extra slices MST SAG TRA B0-fieldmap VEN_BOLD_SWI 3D_FLAIR Whole cranium No extra slices TRA1 TRA SAG ; music off, wakefullness level notation contrastinjection 0,2 ml/kg dotarem T2FFE T1_SE_tra T1_SE_cor 4 min post injection TRA2 TRA2 COR Angulation corpus callosum Angulation corpus callosum Vertical on TRA after gado Total scan time = 50 min!
16 MRI protocol Scans for study HA-PCI 3T MRI Naam Type Oriëntatie Survey MPRAGE_adni fmri No extra slices MST SAG TRA B0-fieldmap VEN_BOLD_SWI 3D_FLAIR Whole cranium No extra slices TRA1 TRA SAG ; music off, wakefullness level notation contrastinjection 0,2 ml/kg dotarem T2FFE T1_SE_tra T1_SE_cor 4 min post injection TRA2 TRA2 COR Angulation corpus callosum Angulation corpus callosum Vertical on TRA after gado Total scan time = 50 min! 31 MRI protocol HA-PCI 3T MRI Diagnostic scans for radiologist (brainmetastases?) Naam Type Oriëntatie Survey MPRAGE_adni fmri_test_2s No extra slices MST SAG TRA B0-fieldmap VEN_BOLD_SWI 3D_FLAIR Whole cranium No extra slices TRA1 TRA SAG ; music off, wakefullness level notation contrastinjection 0,2 ml/kg dotarem T2FFE T1_SE_tra T1_SE_cor 4 min post injection TRA2 TRA2 COR Angulation corpus callosum Angulation corpus callosum Vertical on TRA after gado Total scan time = 50 min!
17 Implementation in CZE time table May 2013: Feasibility study with regard to MRI scans November 2013: METC application for local advice Feb 2014: visit the Netherlands Cancer Institute Feb 2014: training RTT s for taking neurocognitive tests Feb 2014: QA MRI & setup MRI protocol with radiology department Feb-April 2014: develop HA-PCI radiation technique April 2014: start study, feedback on first 3 patients Duration of patient inclusion period of the study is estimated to be 4 years Structures for treatment planning Delineation: - Hippocampi on MRI (delineation atlas available) - Brain - Eye lenses - Avoidance PTV = (brain+4mm) (hippo+5mm)
18 Treatment planning: constraints Variable 25 Gy / 10 fractions V 95% PTV 95 % D 98% PTV Gy (75 %) V 115% PTV 1 % D 1% PTV Preferably 27.5 Gy (110 %) D max PTV Gy (115 %) Mean dose hippocampus left 8.5 Gy Mean dose hippocampus right 8.5 Gy D 1% hippocampus left 10 Gy D 1% hippocampus right 10 Gy Max dose Lenses 10 Gy Treatment planning VMAT planning with 2 dual arcs without couch rotation 95% isodose 10 Gy isodose
19 Treatment planning Challenge for the linac Treatment delivery QA measurement with Delta-4 phantom will be performed for each patient
20 Implementation in CZE time table May 2013: Feasibility study with regard to MRI scans November 2013: METC application for local advice Feb 2014: visit the Netherlands Cancer Institute Feb 2014: training RTT s for taking neurocognitive tests Feb 2014: QA MRI & setup MRI protocol with radiology department Feb-April 2014: develop HA-PCI radiation technique April 2014: start study, feedback on first 3 patients Duration of patient inclusion period of the study is estimated to be 4 years Implemented protocols and workflow - Consult with radiation oncologist and trial explanation - informed consent - Patient logistics by research nurse: - CT, MRI, neurocognitive tests & interview radiotherapist on 1 day - Documentation study - MRI protocol at radiology department - Work instructions and scripts for planning - Medical protocol: - Preparation: - Hybrid cast with individual headrest - CT: 1.2 mm slices; fusion with MRI images - Planning: 2 lateral fields (PCI) or VMAT plan (HA-PCI) - Treatment: Position verification using CBCT
21 Apart verlengstuk versneller-tafel Treatment execution: CBCT scan
22 The possible role of RTT s in the implementation of this trial - Multi-disciplinary approach; radiotherapist, physicist, dosimetrist, RTT, research nurse, radiology dept. - RTT s can perform and process NC-tests - RTT s can test new planning techniques - RTT s can perform specific radiation techniques - By this RTT s can expand their capacities - RTT s can do a presentation about this trial on a conference Aknowledgements Katrien de Jaeger, radiation oncologist CZE Mariska de Smet, clinical physicist trainee Helma van Berkum, research nurse CZE Paul van Haaren, clinical physicist CZE Maarten van Lieshout, RTT CZE Anke Habraken, RTT CZE Fanny van Aarle, RTT CZE Rob van den Bogaard, ICT CZE Dennis Hellegers, dosimitrist CZE Astrid van de Munckhof, CZE Danny Schuring, clinical physicist CZE Cindy Maandag, radiology CZE Tom Budiharto, radiation oncologist CZE Roxane Kuijs, RTT CZE Antoinette van Mill, RTT CZE Marleen Kohler, radiology CZE John Wondergem, radiologist CZE Jose Belderbos, radiation oncologist NKI Linda Glaser, physician assistant NKI Emmy Lamers, RTT NKI Casper Carbaat, RTT NKI Eugene Damen, clinical physicist NKI Michiel de Ruiter, MRI NKI Anne Lisa Wolf, clinical physicist trainee NKI Sanne Schagen, neuropsychologist NKI Stephanie Bogaert, Ghent University Hospital Patricia Clement, Ghent University Hospital
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