Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Radioembolization is an established treatment option for patients with unresectable primary and secondary liver tumors. Microspheres containing 90Y are injected intraarterially to deliver a high radiation dose to the tumors. Despite of our knowledge on the effectiveness of 90Y glass microspheres in the treatment of HCC, literature data on the treatment of metastatic colorectal cancer (mCRC) patients with 90Y glass microspheres is limited. In the recent EANM guideline variable healthy liver doses are recommended for patients with mCRC with an effective tumor dose recommendation based on a study with limited number of patients.
Primary objectives; Investigate effective tumor dose and safe healthy liver dose in radioembolization for colorectal cancer liver metastasis using multicompartment dosimetry Secondary objectives; Investigate dose-response and dose-toxicity relationships, time to progress, concordance between pretreatment and posttreatment dose calculations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group | Patients who received radioembolization for colorectal cancer liver metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therasphere | Device | Transarterial radioembolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| effective tumor dose and safe healthy liver dose | Compare the mean effective tumor doses effective tumour dose (in Gy) of patients with or without response to radioembolization for colorectal cancer liver metastasis. | 3th month after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| dose (in Gy) -response and dose (in Gy)-toxicity relationships | Investigate dose-response and dose-toxicity relationships after transarterial radioembolization. | 6th month after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
No PET-CT, CT or MR of the liver 2-4 months after radioembolization Poor image quality Previous local treatment or surgery for the liver
Not provided
Not provided
Not provided
Adult patients with metastatic colorectal cancer (mCRC) treated using Y90 glass microspheres in lobar or segmental fashion
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University Medical School | Adana | Turkey (Türkiye) | ||||
| Ankara University Medical School |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 29, 2024 | |
| Unrelease | Sep 16, 2024 | |
| Release | Sep 16, 2024 | |
| Reset | Nov 15, 2024 | |
| Release | Nov 19, 2024 | |
| Reset | Jan 3, 2025 | |
| Release | Jan 5, 2025 | |
| Reset | Jan 30, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 29, 2024 | Sep 16, 2024 | |||
| Sep 16, 2024 |
Not provided
Not provided
Not provided
| Ankara |
| Turkey (Türkiye) |
| Hacettepe Univeristy Medical School | Ankara | Turkey (Türkiye) |
| Istanbul University Capa Medical School | Istanbul | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical School | Istanbul | Turkey (Türkiye) |
| Marmara University Medical School | Istanbul | Turkey (Türkiye) |
| Yeditepe University Medical School | Istanbul | Turkey (Türkiye) |
| Dokuz Eylul University Medical School | Izmir | Turkey (Türkiye) |
| Nov 15, 2024 |
| Nov 19, 2024 | Jan 3, 2025 |
| Jan 5, 2025 | Jan 30, 2025 |