Patients with malignancy, suspected of Pulmonary Tumor Thrombotic Microangiopathy (PTTM)
Conditions
Interventions
Imatinib (100-200 mg/day) given on everyday (off-label)
Sponsors
Minatsuki Shun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Over all survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Change in hemodynamics 2)change in BNP 3)changes in PaO2, SaO2 or SpO2 4) changes in PDGF, VEGF, TF, OPN 5)Quality of life measured by emPHasis-10 6)changes in 6 minites walk distance (if available) 7)time to re-admission 8) concentration of imatinib (peak, trough) 9) association between pathology and treatment reactivity, (positive rate of pulmonary wedge cytopathology) | — |
Contacts
Public ContactMai Shimbo
The University of Tokyo Hospital
Outcome results
None listed