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临床试验/CTRI/2024/06/068822
CTRI/2024/06/068822招募中2 期

Role of Transarterial Radioembolisation in Metastatic Lung Lesions

Bela Jain senior resident1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
9
试验地点
1
主要终点
size of lung lesion to be measured on FDG PET CT to see for any reduction in size/resolution

研究概览

简要总结

Primary objectives ·       To assess the  feasibility of transarterial radioembolization in treating metastatic lung tumors ·       Assessment of clinical efficacy of transarterial radioembolization in metastatic lung lesionsRadioembolisation Procedure

CTBA will be acquired in standard institutional split bolus protocol prior to procedure and images will be reviewed to detect the location, number, diameter (maximum, in mm), and origin of culprit artery. Target lesion diameter and its distance from the hilum and pleura will also be recorded.  Tumor volume will be calculated by drawing 3-d VOI around the obtained images. Three volumes of interest (VOIs) will be determined to perform the dosimetry: Tumoral volume (TV), which is the volume of the targeted pulmonary lesion, and non-tumoral volume (NTV), discretizing this one into ipsilateral lung non-tumoral volume (iNTV), which is the healthy tissue within the ipsilateral lung, and contralateral lung non-tumoral volume (cNTV), which is the healthy tissue volume in contralateral lung.  Acquired images will be processed for the estimated     dose received in target lesions and healthy tissues. For radioembolization procedure patent catheter in the predominant tumor feeding bronchial artery will be established. The treatment dose will be determined using above mentioned scan findings. Once the activity is defined, after catheterization of the bronchial artery, the therapeutic radiopharmaceutical will be administered. Radioembolisation agent (Y-90 microspheres or Re-188 lipiodol) will be slowly infused to the target artery, avoiding backflow. After treatment, the patient will undergo post-therapy imaging in nuclear medicine department to ensure the proper distribution of the radiopharmaceutical and post-therapy dosimetry. After the procedure, any adverse effects (cough, rash, vomiting, fever, fatigue, etc.) shall be documented. Laboratory test results (complete blood count and complete metabolic panel, coagulation profile) will be obtained 2 weeks after the procedure and repeated at 6 weeks, 3 months and 6 months follow up. Pulmonary function tests will be done at 6 weeks, 3 months and 6 months post-therapy. For toxicity in lab parameters, latest Common Terminology Criteria for Adverse Events (CTCAE) will be preferred to wherever applicable. If any toxicity occurs such as, hematological toxicities will be initially treated with growth factors and transfusions and further if not responding with growth factors and transfusions, it shall be treated with stem cell rescue. Pulmonary toxicity will be treated according to standard established guidelines for treatment of respiratory distress or restrictive airway disease. Response to treatment will be evaluated at 6 weeks and 3 months after the procedure, using the modified Response Evaluation Criteria in Solid Tumors (mRECIST version 1.1) and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria. CECT parameters like tumor diameter, maximum cross-sectional diameters, tumor volume, tumor enhancement and PET parameter the peak standardized uptake value corrected for lean body mass (SULpeak peak SUL in a spherical 1-cm3 VOI) will be chosen to assess the response.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • measureable metastatic lung lesions (Biopsy proven or positive on FDG PET CT), ECOG less than or equal to 2, Karnofsky score more than 60, Hemoglobin more than 9 g/dl, WBC more than 1500/microlitre, platelets more than 50000/microlitre, PT less than 1.3 and INR less than 1.5, FEV1more than 60%, serum creatinine less than 1.3.

排除标准

  • previous history of interstitial lung disease, COPD, active lung infection, pulmonary hypertension, pulmonary AV malformation, Symptomatic heart failure, LBBB, Predictive dose to lung parenchyma exceeding 30 Grey in dose planning, allergy to contrast/plastic, renal failure, coagulative disorder, survival expectancy of less than 3 months.

结局指标

主要结局

size of lung lesion to be measured on FDG PET CT to see for any reduction in size/resolution

时间窗: 6 weeks, 3 months

次要结局

  • To establish the dose response relationship of transarterial radioembolization in metastatic lung lesions using volumetric methods. Response to be assessed using FDG PET CT(6 weeks, 3 months)

研究者

发起方
Bela Jain senior resident
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shamim A Shamim

AIIMS, New Delhi

研究点 (1)

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