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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - BE | Experimental | Lobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis. |
|
| Arm 2 - TACE | Experimental | Lobar or segmental lipiodol conventional transarterial chemoembolization (TACE). Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres. |
|
| Arm 3 - DEB - CLOSED | Experimental | Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU monthly until entire tumor burden is treated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bland Embolization | Device | Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal MRI/Triple Phase CT | Hepatic progression-free interval (H-PFS) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Symptom-relief interval and toxicity | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating women may not participate due to the embryotoxic effects of protocol treatment. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Prior hepatic arterial therapy or hepatic radiation therapy. Prior surgical resection or ablation of liver metastases is acceptable. Patients must be at least one month beyond prior chemotherapy, PRRT, ablation or surgery, and have recovered from all therapy-associated toxicities.
Active infection (Symptomatic bacterial and fungal infection - newly diagnosed and/or requiring treatment);
Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla
Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).
Contraindications to arteriography and selective visceral catheterization:
Contraindications to hepatic artery embolization:
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| Name | Affiliation | Role |
|---|---|---|
| Michael C Soulen, MD, FSIR | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30016989 | Derived | Chen JX, Wileyto EP, Soulen MC. Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial. Trials. 2018 Jul 17;19(1):390. doi: 10.1186/s13063-018-2782-5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2026 | |
| Reset | May 4, 2026 |
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| Transarterial chemoembolization | Combination Product | Lobar or segmental lipiodol transarterial chemoembolization. Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres. |
|
|
| Drug Eluting Beads Embolization | Combination Product | CLOSED - Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU. |
|
|
| Standford |
| California |
| 94305 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hospital Italiano de Buenos Aires | Buenos Aires | C1191 ABH | Argentina |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N3M5 | Canada |
| Ospedale San Raffaele | Milan | 20132 | Italy |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2026 | May 4, 2026 |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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