The objective is to test the hypothesis that radiotherapy for lung cancer induces an increase in pulmonary artery pressure.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in pulmonary artery pressure 6 and 12 weeks after completion of
chemoradiotherapy reference to baseline using cardiac MRI.
Secondary outcome
• Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function;
pulmonary artery distensibility 6 and 12 weeks after completion of
chemoradiotherapy reference to baseline.
• The assessment of RV-dimensions and RV-function 6 and 12 weeks after
chemoradiotherapy reference to baseline.
• The incidence of clinical signs of radiation pneumonitis according to
SWOG-criteria 6 weeks after completion of treatment
• The incidence of radiological signs of pulmonary fibrosis according to
CTCAE4.0 12 weeks after completion of treatment .
Background summary
In the radiotherapeutic treatment of lung cancer, the dose that can be safely
applied to the tumour is limited by the risk of radiation induced lung damage.
This damage is characterized by parenchymal damage and vascular damage. In
rats, we have found that radiation-induced vascular damage results in increased
pulmonary artery pressure. Interestingly, the consequent loss of pulmonary
function could be fully explained by this increase in pulmonary artery
pressure. We hypothesize that also in patients a radiation induced increase in
pulmonary artery pressure can be observed after radiotherapy, which may
contribute to the development of radiation pneumonitis.
Study objective
The objective is to test the hypothesis that radiotherapy for lung cancer
induces an increase in pulmonary artery pressure.
Study design
Observational pilot study.
Study burden and risks
If safety procedures are followed, with appropriate screening for
contra-indications, repeated MRI poses no risk to patients.
Hanzeplein 1
9700 RB
NL
Hanzeplein 1
9700 RB
NL
Listed location countries
Age
Inclusion criteria
. WHO PS 0-2
. Stage IIIA or IIIB non-small cell lung cancer
. Planned for 25 x 2.4 Gy, with concomitant chemotherapy
Exclusion criteria
Contra-indications for undergoing MRI-scans:;Absolute contra-indications:
• ICD (implanteerbare cardioverter-defibrillator)
• All pacemakers except for the SureScan (Medtronic) (under conditions) ;Relative contra-indications
• Prior pacemaker wires
• Clips, stents
• Non-removable hearing aids
• Non-removable insulin pumps
• Nerve stimulators
• Metal fragments in the eyes
• Inflatable breast implants
• Severe claustrophobia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37007.042.11 |