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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-13239 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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| Name | Class |
|---|---|
| Sirtex Medical | INDUSTRY |
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A prospective, interventional study evaluating the safety of Y-90 TARE for tumor control of the right side and induction of left liver hypertrophy as part of a planned single-stage or two-stage hepatectomy for patients with CLM and insufficient FLR at the time of presentation.
Primary Objective:
To examine the safety and feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM.
Secondary Objectives:
To describe changes in liver volume after Y-90 TARE, including:
To describe additional interventional procedures needed to induce additional hypertrophy if insufficient hypertrophy from Y-90 TARE
To assess the proportion of TARE patients who undergo attempted and complete curative-intent resection of CLM
To assess measures of disease control, including:
To describe Patient Reported Outcomes using MDASI-GI
To assess FLR liver quality, right-sided surgical adhesions from TARE intraoperatively
To describe dosimetry of individual liver lesions - using SPECT/CT, CT, and pathology correlation
To describe change in liver function measured by the pre- and post-TARE HIDA SPECT/CT scans and hepatic function blood tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yttrium-90 | Experimental | Help to control the tumor(s) on the right side of the liver while the remaining left side of the liver, which is clear of cancer, grows. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yttrium-90 (Y-90) resin microspheres | Drug | Given by scan |
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| Measure | Description | Time Frame |
|---|---|---|
| The evaluation from using the feasibility of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM. | through study completion, an average of 1 year | |
| The evaluation of using the safety of Y-90 TARE directed to the right hemi-liver for induction of left liver FLR hypertrophy as part of a planned hepatectomy for patients with CLM. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ching-Wei Tzeng, MD | Contact | (713) 792-0386 | cdtzeng@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Ching-Wei Tzeng, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000615496 | Yttrium-90 |
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