| CTRI Number |
CTRI/2024/01/062021 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Studying the role of 18FDG PET-CT in understanding the metabolism of lung cancers, including Adenocarcinoma and Squamous Cell Carcinoma. |
|
Scientific Title of Study
|
18FDG PET-CT metabolic parameters in Adenocarcinoma and Squamous Cell Carcinoma of Lung. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehul Dulet |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Nuclear Medicine, AIIMS, Jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9672727321 |
| Fax |
|
| Email |
drduletmehul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Nuclear Medicine, AIIMS, MIA 2nd Phase, Basni, Jodhpur, Rajasthan, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
02912831467 |
| Fax |
|
| Email |
rajesh.nmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mehul Dulet |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Nuclear Medicine, AIIMS, Jodhpur, Rajasthan, India
RAJASTHAN
342005
India |
| Phone |
9672727321 |
| Fax |
|
| Email |
drduletmehul@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
All India Institute of Medical Sciences (AIIMS), MIA 2nd Phase, Basni, Jodhpur |
| 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 Mehul Dulet |
AIIMS, Jodhpur |
Department of Nuclear Medicine, Radiology Block, All India Institute of Medical Sciences, MIA 2nd Phase, Basni, Jodhpur
Jodhpur
RAJASTHAN |
9672727321
drduletmehul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Jodhpur - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C34||Malignant neoplasm of bronchus andlung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years.
2. Diagnosed cases of Adenocarcinoma and Squamous Cell Carcinoma of lung.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and breastfeeding women.
2. Non-compliant patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will help us to understand the variation in glucose metabolism among cases of Adenocarcinoma and Squamous Cell Carcinoma of lung.
|
After scan acquisition. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study may be beneficial in identifying the two common subtypes of Lung cancer on the basis of 18FDG PET-CT metabolic parameters.
|
After scan acquisition. |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
19/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
Will 18FDG PET-CT metabolic parameters be able to differentiate between the two common subtypes of lung cancer - Adenocarcinoma and Squamous Cell Carcinoma in diagnosed patients?
It will be a cross-sectional study in patients of either sex and age group more than or equal to 18 years who have been diagnosed with Squamous Cell Carcinoma or Adenocarcinoma of lung which will be referred to the Department of Nuclear Medicine, AIIMS Jodhpur for 18FDG PET-CT. Patients will be asked to fast for 4-6 hours for the required serum glucose of <200 mg/dL. 18FDG (0.1 – 0.2 mCi per kg body weight) will be administered intravenously and scan will be acquired after 45-60 minutes in supine and raised arms position. Five metabolic parameters will be calculated from the acquired scan and interpreted for their associations with Adenocarcinoma and Squamous Cell Carcinoma.
Aim: To study the association of various 18FDG PET-CT metabolic parameters with Adenocarcinoma and Squamous Cell Carcinoma of lung.
Objectives: Primary objective - To differentiate between Adenocarcinoma and Squamous Cell Carcinoma of lung on the basis of 18FDG PET-CT metabolic parameters. Secondary objective: To identify the 18FDG PET-CT metabolic parameter having the best correlation with Adenocarcinoma and Squamous Cell Carcinoma of lung.
Inclusion Criteria: Age more than or equal to 18 years. Diagnosed cases of Adenocarcinoma and Squamous Cell Carcinoma of lung.
Exclusion criteria: Pregnant and breastfeeding women. Non-compliant patients.
Outcomes: This study will help us to understand the variation in glucose metabolism among cases of Adenocarcinoma and Squamous Cell Carcinoma of lung. This study may be beneficial in identifying the two common subtypes of Lung cancer on the basis of 18FDG PET-CT metabolic parameters. |