Evaluation of radiation induced pulmonary hypertension using MRI in stage III NSCLC patients treated with chemoradiotherapy. A Pilot Study.

Evaluation of radiation induced pulmonary hypertension using MRI in stage III NSCLC patients treated with chemoradiotherapy. A Pilot Study. - Radiation induced pulmonary hypertension

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35880

Enrollment

Registered

2011-09-21

Start date

2012-09-03

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer pulmonary hypertension

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Changes in pulmonary artery pressure 6 and 12 weeks after completion of chemoradiotherapy reference to baseline using cardiac MRI.	—

Secondary

Measure	Time frame
• 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 .	—

Measure

Time frame

• 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 .

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Countries

Netherlands

Outcome results