| 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
|
|
|
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
|
|
|
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 ProcedureCTBA 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. |