Exploratory Study to Assess the Predictive Value of 99mTc-labeled Albumin Spheres for the Intrahepatic Distribution of 90Y SIR Spheres in Patients With Liver Metastases of Colorectal Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: between 18 and 85 years
- •if female, postmenopausal or surgically sterilized
- •liver metastases of a colorectal tumor in both liver lobes
- •scheduled for therapy with 90Y SIR spheres for clinical reasons
- •life expectancy longer than 6 months
- •willing and able to undergo all study procedures
- •having voluntarily provided written and fully informed consent
排除标准
- •presenting with a contraindication to 90Y SIR spheres therapy
- •variants of the arterial hepatic blood supply which interfere with the objectives of this study (e.g., variants of Michel)
- •women who are pregnant, lactating or who are of childbearing potential
- •patients being clinically unstable
- •uncooperative, in the investigator's opinion
- •any contraindication to SIRT treatment
- •any concomitant chemotherapy
- •shunt to the lung >10%
- •shunt to any extrahepatic organ (except the lung)
- •having been previously enrolled in this study
- •participating in another prospective clinical trial
研究组 & 干预措施
99mTc- labeled albumin macroaggregates (MAA)
Diagnostic MAA- SPECT- imaging.
干预措施: MAA for diagnostic SPECT imaging (Drug)
99mTc- labeled albumin microspheres (B20)
Diagnostic B20- SPECT- imaging.
干预措施: Diagnostic B20- SPECT imaging. (Drug)
结局指标
主要结局
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
时间窗: Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
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.)
次要结局
- Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20.(One day prior to SIRT)
- Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy(Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy)
- Adverse events as elicited upon indirect questioning.(At any visit.)
研究者
Jens Ricke
Prof. Dr.
University of Magdeburg