No registrations found.
ID
Source
Brief title
Health condition
Non-small cell lung cancer.
Sponsors and support
ef.smit@vumc.nl
Intervention
Outcome measures
Primary outcome
Tumour perfusion change after sildenafil.
Secondary outcome
N/A
Background summary
The aim of this pilot study is to assess if sildenafil induced pulmonary vasodilatation leads to an associated increase in tumour blood flow in NSCLC. If this appears to be the case then a larger scale study would be performed to confirm this as sildenafil might then potentially augment the efficacy of chemotherapy or act as a radiosensitising agent in the treatment of NSCLC.
A baseline dynamic CT perfusion scan will be performed to assess baseline tumour perfusion. On the treatment day patients will receive 50 mg sildenafil orally (time point 0). One hour after administration a CT perfusion will be performed to assess tumour perfusion post sildenafil. By comparing the baseline and post-treatment scans the effect on tumour perfusion will be estimated. Blood pressure and pulse will be monitored at 0, 15, 30, 45, 60 and 120 mins to assess for possible systemic hypotension.
Study objective
Does sildenafil improve tumour perfusion?
Study design
Baseline and 1 hour post sildenafil.
Intervention
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 sildenafil administration (Ie. Same time points as CT
scans). The primary outcome of change in tumor perfusion will be
assessed by the CT scans and PET scans.
Department of pulmonary diseases
PO Box 7057
Joline Lind
Amsterdam 1007 MB
The Netherlands
j.lind@vumc.nl
Department of pulmonary diseases
PO Box 7057
Joline Lind
Amsterdam 1007 MB
The Netherlands
j.lind@vumc.nl
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
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
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 |
|---|---|
| NTR-new | NL1088 |
| NTR-old | NTR1121 |
| Other | MEC nr : 07/237. |
| ISRCTN | Geen aanvraag/Observational study |