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This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives:
The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraSphere® | Device | TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients given access to treatment with TheraSphere. | The number of eligible patients provided with supervised access to treatment with TheraSphere with primary cancer to the liver who are not surgical resection candidates. | 24 months |
| Evaluate patient experience with Therasphere. | Evaluation of patient experience and toxicities associated with Therasphere via patient follow-ups with clinician notes. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response to treatment with TheraSphere® | Diagnostic imaging studies for assessment of tumor response will be performed according to usual standard of care as established by the referring oncologist. | 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
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Patients from St. Joseph Hospital of Orange, community members in the St. Joseph Hospital service area and surrounding areas
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Wagman, M.D., F.A.C.S. | St. Joseph Hospital of Orange | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |