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SWARM_Systemic release of growth factors after radioembolization of hepatic malignancies

ABSTRACT: Interventions: Group 1: The radioembolization in hepatic malignancies is a routine clinical procedure. Serum samples for growth factor determination from peripheral venous blood are taken at three points in time - before therapy, after the first radioembolization and before the second radioembolization. Study procedure ends after the third blood sample has been taken. The second therapy for SIRT and the follow-up examinations belong to the scope of routine clinical procedures/follow-up. Primary outcome(s): Evaluation of growth hormone release as a prognostic marker for overall survival after local ablative radioembolization therapy (SIRT) of hepatic malignancies. Study Design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: basic science

DISEASE(S): Secondary Malignant Neoplasm Of Small Intestine,Breast, Unspecified,Secondary Malignant Neoplasm Of Liver And Intrahepatic Bile Duct,Secondary Malignant Neoplasm Of Large Intestine And Rectum,Liver Cell Carcinoma

PROVIDER: 2721073 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: The standard treatment is Radiofrequency Ablation (RFA) for colorectal liver metastases (CRLM). Patients will not be randomized. All patients will additionally be treated with Yttirum-90 Radioembolization, one month after the RFA procedure. The RFA procedure can be performed percutaneously, laparoscopically or during an open procedure. The duration of the RFA procedure depends on the surgical approach and the number of the lesions. One or two weeks prior to the radioembolization procedure, each patient will undergo pre-procedural screening by means of hepatic angiography and subsequently technetium-99m-labelled albumin macroaggregates (99mTc-MAA) injection, followed by planar imaging and Single Photon Emission Computed Tomography (SPECT). The pre-procedural angiography permits visualization of the anatomy of the vessels and provides an opportunity to embolize arteries if necessary (to spare the gastric and duodenal arterial flow from incorporating radioactive spheres). The 99mTc-MAA and the subsequent nuclear imaging will determine the presence of any shunts from the hepatic arterial system to the pulmonary or gastrointestinal venous systems. Both the pre-procedural screening and the radioembolization procedure will take about 2 tot 3 hours depending on the hepatic vascular anatomy. Patients will be admitted the day before the procedure and discharged the day after the procedure. The main study parameter is the local liver recurrence rate after RFA combined with Yttrium-90 radioembolization for patients with CRLM. This will be assessed by the number and percentage of patients with local liver recurrence, 12 months after the RFA procedure. Local liver recurrence is defined as: radiologic detection of residual or recurrent viable tumor which is related to the ablation Primary outcome(s): Local Liver Recurrence Rate (defined as radiologic detection of residual or recurrent viable tumor which is related to the ablation zone, located in the same segment as the treated lesion) Study Design: N/A: single arm study, Open (masking not used), N/A , unknown, Crossover

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SWARM_Systemic release of growth factors after radioembolization of hepatic malignancies

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