| CTRI Number |
CTRI/2024/07/071022 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing methods to contour organs at risk in Lung Cancer patients: Manual vs. Computerized Approach. |
|
Scientific Title of Study
|
Comparison of Manual Contouring and Atlas Based Autosegmentation in Patients of Lung Cancer. |
| 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 Dipti Singh |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh, India |
| Address |
Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12 , Chandigarh
Pin : 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8840548919 |
| Fax |
|
| Email |
dipsthedr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Khosla |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh, India |
| Address |
Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12 , Chandigarh
Pin : 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876638478 |
| Fax |
|
| Email |
dr_divya_khosla@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Khosla |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh, India |
| Address |
Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12 , Chandigarh
Pin : 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876638478 |
| Fax |
|
| Email |
dr_divya_khosla@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room No. 54, Nehru hospital extension, department of radiotherapy and oncology, PGIMER, Chandigarh. 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Room no 54, Nehru Hospital Extension, Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12 , Chandigarh
Pin : 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dipti Singh |
PGIMER, Chandigarh |
Room No. 54, Nehru hospital extension, Department of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12 , Chandigarh
Pin : 160012
Chandigarh
CHANDIGARH |
8840548919
dipsthedr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committee , Chandigarh (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Histologically confirmed Non-small cell lung cancer (NSCLC)
patients who are referred for definitive treatment (chemoradiation
or SBRT).
2)ECOG 0, 1 or 2.
3)Ability to understand and the willingness to sign and informed consent. |
|
| ExclusionCriteria |
| Details |
1) Patients who has metastatic disease.
2) Patients who has received prior Radiotherapy for lung cancer to thoracic region.
3) Pregnant or lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To create a new customised Atlas for Lung cancer patients.
2)To compare manual contouring with auto segmentation in terms of overall contouring time and accuracy using various evaluation metrics like DICE ratio, Hausdorff distance and Volume ratio. |
After completion of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dosimetric analysis between manually segmented contours and auto segmented contours by evaluating maximum and mean doses received by various Organs at Risk. |
After 1 year. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Radiation has an integral role in all stages of lung cancer. In order to deliver therapeutic doses to the target while also protecting the Organs at Risk (OARs), a proper therapeutic plan must be developed which requires a highly precise Target volumes (TVs) and OARs delineation which can be a challenging task. Contouring is the essential and most important part of Radiotherapy treatment planning. However there is an option of Autosegmentation in various softwares. But it is not validated for lung cancer patients in India. This study will validate the auto segmentation softwares in terms of accuracy, time reduction and its application in clinical practice. The library created can then be outsourced and can be used as reference for other centres. |