Reduction of organ motion during radiotherapy by non-invasive mechanical ventilation supported breathing control.

Conditions: Cancer (breast cancer, mediastinal tumours, lung cancer, liver tumours and pancreatic cancer). (Note: we will also include healthy volunteers).

Registration Number: NL-OMON24117

Lead Sponsor: Amsterdam UMC - Radiotherapy

Brief Summary: A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 90

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

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 <30% of predicted)
•resting PetCO2 >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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.:<br>•subjects’ comfort with the different breathing control strategies has been assessed using a short questionnaire;<br>•cost effectiveness in terms of time investment has been analysed.<br>