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CTRI Number  CTRI/2024/06/068822 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Single Arm Study 
Public Title of Study   Embolisation of metastatic lung lesions using radiopharmaceutical Yttrium -90 in patients with various malignancies to decrease metastatic disease burden 
Scientific Title of Study   Role of Transarterial Radioembolisation in Metastatic Lung Lesions 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shamim A Shamim 
Designation  Additional Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Nuclear Medicine, AIIMS, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  sashamim2002@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bela Jain 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of Nuclear Medicine, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9458289669  
Fax    
Email  bela1102@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Bela Jain 
Designation  Senior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of Nuclear Medicine, AIIMS New Delhi


DELHI
110029
India 
Phone  9458289669  
Fax    
Email  bela1102@yahoo.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, India (Pin Code 110029) 
 
Primary Sponsor  
Name  Bela Jain senior resident 
Address  Department of Nuclear Medicine, AIIMS, New Delhi, India (pincode 110029) 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bela Jain  AIIMS  Department of Nuclear Medicine (PET CT, room 7) & Department of Radiodiagnosis (Interventional Radiology)
South
DELHI 
9458289669

bela1102@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C800||Disseminated malignant neoplasm, unspecified, (2) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Y-90 microsphere radioembolisation  transarterial radioembolisation with the above mentioned agent to be done via the predominant tumor feeding pulmonary or bronchial artery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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  
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
size of lung lesion to be measured on FDG PET CT to see for any reduction in size/resolution  6 weeks, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="9"
Sample Size from India="9" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Primary objectives

·       To assess the  feasibility of transarterial radioembolization in treating metastatic lung tumors

·       Assessment of clinical efficacy of transarterial radioembolization in metastatic lung lesions

Radioembolisation 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.

 
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