Pilot Study assessing sildenafil effect on lung tumour blood flow

Not yet recruiting

• Conditions: non-small cell lung cancer; 10038666; lung cancer

• Registration Number: NL-OMON31434
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Age > 18 years
2. WHO performance status 0-1
3. Adequate hematological, renal and hepatic functions
a. total bilirubin < 1.5 x UNL
b. ASAT/ALAT < 2 x UNL
c. alkaline phosphatase < 5 x UNL
d. creatinine < 130 mmol/L
4. Primary tumour size >=3cm
5. Written informed consent

Exclusion Criteria

1. Concurrent NTG, ritonivir, azoles, other P450 inhibitors
2. Concurrent anti-hypertensive or nitrate medications
3. Hypersensitivity to sildenafil/component of formulation
4. Contrast allergy
5. Hypotension <90/50mmg
6. Other serious diseases such as heart failure, unstable angina, MI/CVA/serious arrhythmia within 6 months, diabetes
7. History of visual loss and genetic degenerative retinal disease e.g. retinitis pigmentosa
8. Pregnancy/lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The baseline and post-sildenafil tumour perfusion will be compared using the<br /><br>Wilcoxon signed-rank test to assess any change in tumour perfusion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>