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van CCT (UK)

van CCT (UK)

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

- candidate number2864
- NTR NumberNTR1121
- ISRCTNGeen aanvraag/Observational study
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-nov-2007
- Secondary IDs07/237. MEC nr
- Public TitleObservational study;
Pilot study assessing sildenafil effect on lung tumour blood flow.
- Scientific TitleObservational study;
Pilot study assessing sildenafil effect on lung tumour blood flow.
- hypothesisDoes sildenafil improve tumour perfusion?
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC)
- Inclusion criteria1. 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 1cm;
5. Written informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2007
- planned closingdate1-apr-2008
- Target number of participants10
- Interventions1. 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.
- Primary outcomeTumour perfusion change after sildenafil.
- Secondary outcomeN/A
- TimepointsBaseline and 1 hour post sildenafil.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Centre, Department Pulmonary Diseases
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD6-nov-2007 - 12-nov-2008

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