Safety and efficacy of imatinib therapy administered in patients with Pulmonary Tumor Thrombotic Microangiopathy (PTTM) : A prospective study
- Conditions
- Patients with malignancy, suspected of Pulmonary Tumor Thrombotic Microangiopathy (PTTM)
- Registration Number
- JPRN-jRCTs031210263
- Lead Sponsor
- Hatano Masaru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
1)Pulmonary hypertension (mean pulmonary artery pressure over 25 mmHg by right heart catheterization or RVSP over 40 mmHg by echocardiography)
2)cancer (diagnosed or suspected)
3)sign of right heart failure
4)hypoxemia
5)age over 20 year-old
6)sex both
7)Written informed consent
8)available as out-patient after discharge
1)severe liver dysfunction, renal dysfunction or cardiovascular disease (not due to right heart failure)
2)taking Lomitapide within 7 days
3)Total bilirubin > 2.0 x reference value at registration
4)ALT, AST > 4.0 x reference value at registration
5)HBV carrier
6)taking Imatinib due to not PTTM
7)allergy or severe side effect to Imatinib
8)Pregnant, unwilling to practice contraception during the study
9)lactating female
10)participating other clinical trial within 4 months
11)judged to be inappropriate by physician (in/outpatient)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Over all survival
- Secondary Outcome Measures
Name Time Method 1)Change in hemodynamics<br>2)change in BNP<br>3)changes in PaO2, SaO2 or SpO2<br>4) changes in PDGF, VEGF, TF, OPN<br>5)Quality of life measured by emPHasis-10<br>6)changes in 6 minites walk distance (if available)<br>7)time to re-admission<br>8) concentration of imatinib (peak, trough)<br>9) association between pathology and treatment reactivity, (positive rate of pulmonary wedge cytopathology)