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Observational study; Pilot study assessing sildenafil effect on lung tumour blood flow.

Observational study; Pilot study assessing sildenafil effect on lung tumour blood flow.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON19896
Enrollment
10
Registered
2007-11-06
Start date
2007-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Non-small cell lung cancer.

Interventions

1. Baseline CT perfusion scan
2. 50 mg sildenafil
3. 1 hour later: CT perfusion scan. In addition to CT perfusion scans we will perform H2O PET scans to assess tumor perfusion. The PET scans will be performed at baseline and 60 minutes after sildena

Sponsors

Prof. Dr. E.F. Smit ef.smit@vumc.nl
Lead Sponsor

Eligibility

Inclusion criteria

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 ¡Ý1cm; 5. Written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Tumour perfusion change after sildenafil.

Contacts

Public ContactJoline Lind

VU university medical centre Department of pulmonary diseases PO Box 7057

j.lind@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)