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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005609-21 | EudraCT Number |
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| Name | Class |
|---|---|
| Sirtex Medical | INDUSTRY |
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The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres (SIR- spheres).
Patients with metastases of colorectal tumors will be included into this study provided that they are scheduled for 90Y SIR spheres therapy for clinical reasons. Before 90Y SIR spheres therapy, patients will receive a diagnostic examination with injection of MAA (group A) or B20 (group B) into the common hepatic artery to rule out a relevant shunt volume to the lung or other extra-hepatic locations (e.g., stomach) as recommended by the manufacturer. After the diagnostic scan, therapy with SIR- spheres will be conducted in 2 separate sessions with selective injection of 90Y labeled SIR spheres into the right and left hepatic artery at two separate occasions (routine procedure at the University of Magdeburg, Germany). In addition, therapeutic sessions will include the selective injection of MAA or B20 into the right / left hepatic artery according to a predefined plan (either alone or as a mixture with the SIR spheres).The intra-hepatic distribution of 90Y labeled SIR spheres will be assessed using "Bremsstrahlen"- Single- Photon- Emission- Computed- Tomography (SPECT)- imaging, the distribution of MAA and B20 will be assessed using SPECT imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 99mTc- labeled albumin macroaggregates (MAA) | Experimental | Diagnostic MAA- SPECT- imaging. |
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| 99mTc- labeled albumin microspheres (B20) | Experimental | Diagnostic B20- SPECT- imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAA for diagnostic SPECT imaging | Drug | Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy | The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by Tc-99m MAA will be given by a blinded reader in categories by visual assessment (0-10%, >10-20%, >20-30%, …, >90-100%) (only patients who received Tc-99m MAA during evaluation.) | Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy | The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by B20 will be given by a blinded reader in categories by visual assessment (0-10%, >10-20%, >20-30%, …, >90-100%) (only patients who received Tc-99m B20 during evaluation.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Ricke, Prof. Dr. | University of Magdeburg, Faculty for Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Radiology and Nuclear Medicine | Magdeburg | Saxony-Anhalt | 39120 | Germany |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Diagnostic B20- SPECT imaging. | Drug | Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq. |
|
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| Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy |
| Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20. | elimination half-life calculated in [min] from the decay-corrected radioactivity concentration measured over the liver; % radioactivity trapped in the liver at the individual measuring time points (of total radioactivity measured over the liver in the first scan); percent lung shunt (percentage of liver activity leaking to the lung at the individual time points) | One day prior to SIRT |
| Adverse events as elicited upon indirect questioning. | Number of patients with adverse events (AEs), number of AEs per patient; descriptive listing of all AEs | At any visit. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |