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Off study clinical use of Y90 glass microspheres (TheraSphere)
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This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yttrium-90 liver radioembolization | Experimental | Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere) | Device | Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT: up to 5 lesions at baseline and sum longest diameters (SLD).
non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either:
Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow.
Previous radiation therapy to the lungs and/or to the upper abdomen
Pregnancy
Symptomatic lung disease.
Significant extrahepatic disease representing an imminent life-threatening outcome.
Active uncontrolled infection
Any pre-treatment laboratory findings within 30 days of treatment demonstrating:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Fidelman, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
A 2nd radioembolization treatment was allowed if patients had bilobar tumors and were willing to get repeated treatments.
Yttrium-90 radioembolization there were 14 total patients who signed consent and participated in the study. Enrollment started in May2010 and ended in June 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Yttrium-90 Liver Radioembolization 1 Treatment | Patients who received 1 liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 6 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Yttrium-90 Liver Radioembolization | Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at time of first treatment | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain | Posted | Number | participants | 6 months |
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| Secondary | Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by MRI or CT: up to 5 lesions at baseline and sum longest diameters (SLD).
non-target lesions: Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy | Posted | Count of Participants | Participants | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yttrium-90 Liver Radioembolization | Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere) Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery | 0 | 14 | 3 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | NCI CTCAE grade 2 fatigue in two participants NCI CTCAE grade 1 fatigue in one participant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nicholas Fidelman | University of California San Francisco Department of Radiology | (415) 353-1300 | Nicholas.Fidelman@ucsf.edu |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| Participants |
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