Cancer (breast cancer, mediastinal tumours, lung cancer, liver tumours and pancreatic cancer). (Note: we will also include healthy volunteers).
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, subjects must meet all of the following criteria: • age >18 years • adequate communication and understanding skills of Dutch language • referred to or undergoing radiotherapy with DIBH at the department of radiation oncology of the Amsterdam UMC • condition: KPS >70 or WHO PS max 1 (see 4.3 Exclusion criteria) • signed informed consent (IC)
Exclusion criteria
Exclusion criteria: Any potential subject with (a history of) any of the following conditions will be excluded from participation in this study: • asthma controlled by medication • moderately to severely impaired lung function (FEV1 50 mmHg • manifest cardiac failure • epilepsy • hypertension uncontrolled by medication • brain disease, and/or anomalies of the brain’s vasculature or previous TIA/CVA • morbid obesity, i.e. BMI >40 kg/m2 • pneumothorax • renal failure • claustrophobia • current pregnancy • any 3T MRI contra-indications as stated by the AMC MR safety committee Furthermore, patients will be excluded if they have: • any tumour that is not clinically definable on planning CT due to e.g. surrounding consolidation or atelectasis • a tumour located within 2cm radius of main airways and proximal bronchial tree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is the feasibility to achieve regularized breathing, compensated prolonged breath-holding and high frequency ventilation in healthy volunteers and cancer patients to quantify reduced dose to organs at risk as compared to DIBH and FB. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are reached if the practical advantages and limitations of the novel breathing control strategies for routinely radiotherapy delivery in cancer patients have been identified, i.e.: • subjects’ comfort with the different breathing control strategies has been assessed using a short questionnaire; • cost effectiveness in terms of time investment has been analysed. | — |
Contacts
Amsterdam UMC, location Academic Medical Center