None listed
Conditions
Brief summary
The purpose of the study is to provide a real world view of clinical practice, patient outcomes, safety, and the comparative effectiveness of SIR-Spheres treatment in patients with liver cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over and Y90 therapy for the first time as treatment for either primary or secondary liver cancer. Study details The treatment is for primary and secondary liver cancer. The Radiation-Emitting SIR-Spheres In Non-resectable (RESIN) Liver Tumor involves patients with primary and secondary liver cancer receiving (Y90 resin microspheres) treatment as part of their overall oncologic management. The microsphere are injected into the liver through a blood vessel. This allows a large dose of radiation to be delivered to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. All visits and procedures related to SIR-Spheres treatment are performed on an outpatient basis per standard of care. Prior to treatment, patients are assessed by physical examination, radiographic evaluation, and blood tests to determine the health of the patient and liver. Standard of care tests done before this procedure may include: • physical exam and medical history • blood tests requiring about 2 tablespoons of blood • a chest x-ray, CT or MRI scan • an imaging scan (CT or MRI scan) of the liver Patients undergo an initial mapping arteriogram, to determine the distribution of blood vessels to the tumor(s), identify possible vessels which are to be avoided due to supply to the stomach/small bowel, and evaluate the amount of shunting through the tumor(s) to the lungs. This procedure is performed under sterile conditions with patients having a small tube (catheter) inserted through the skin. It is usually inserted into the thigh, into a blood vessel going to the liver. Depending on the size and location of tumors, there may be more than one treatment with SIR-Spheres planned. Repeat treatment is done between 4-8 weeks after the first treatment if there is more disease to treat.
Interventions
Patients will have data collected as part of standard of care insertion of Sir-Spheres for treating their primary or secondary liver tumours. Patient data will be collected and entered into the database at baseline and every six months as long as the patient continues to receive care at the participating site or until the study ends. The study will end when there have been 100 patients enrolled or until the coordinating site decides to shut the study.
Sponsors
Professor Peter Gibbs
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who have selected Y90 therapy for the first time to a treat both primary and metastatic diseases of the liver. 2. Provision of written informed consent. 3. Age 18 and older.
Exclusion criteria
1. Patients who are being re-treated with Y90, even if new areas are being targeted. If patients have received Y90 treatment as part of their first and ongoing round of Y90 therapy, they are eligible to participate.
Outcome results
None listed