Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
With
BTG International Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
18 years of age or older
diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies
unresectable liver metastases
target tumors measurable using standard imaging techniques
tumor replacement \< or = 50% of total liver volume (visual estimation by investigator)
Hypervascular tumors (visual estimation by investigator)
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
minimum one month since most recent prior cancer therapy with the exception of patients receiving Sandostatin for neuroendocrine cancer
patient informed consent
You may not be if
At risk of hepatic or renal failure within 21 days of treatment (serum creatinine \> 2.0 mg/dL unless on dialysis; serum bilirubin ≥ 2.0 mg/dL; albumin \< 2.0 mg/dL or any history of hepatic encephalopathy)
contraindications to angiography and selective visceral catheterization including any non-correctable bleeding diathesis or coagulopathy, severe peripheral vascular disease or history of non-management allergy or intolerance to contrast, narcotics, sedatives or atropine
severe liver dysfunction or presentation of pulmonary insufficiency or clinically evident history of chronic obstructive pulmonary disease
cirrhosis or portal hypertension
prior external beam radiation treatment to the liver
prior TheraSphere treatment to the liver
any intervention for, or compromise of the Ampulla of Vater
clinically evident ascites (trace ascites on imaging is acceptable)
any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before first TheraSphere treatment
significant life-threatening extrahepatic disease in judgment of physician
concurrent enrollment in another study
alternative available therapies in judgement of physician
evidence on technetium-99m macroaggregated albumin scan that shows lung shunting \> 30 Gy cumulative limit
evidence on technetium-99m macroaggregated albumin scan showing potential for deposition of microspheres to the gastrointestinal tract that cannot be eliminated by catheter placement or corrective action using standard angiographic techniques
positive serum pregnancy test in women of childbearing potential
co-morbid disease or condition that puts the patient at undue risk or precludes use of TheraSphere in judgment of physician
