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CTRI Number  CTRI/2022/08/044615 [Registered on: 03/08/2022] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Cushings disease imaging  
Scientific Title of Study   mDesmo Cold kit for PET imaging to localize ACTH dependent Cushing syndrome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jaya Shukla 
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh  
Address  Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  01722756724  
Fax    
Email  shuklajaya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaya Shukla 
Designation  Additional Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh  
Address  Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  01722756724  
Fax    
Email  shuklajaya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rama Walia 
Designation  Assiociate Professor 
Affiliation  Post Graduate Institute of Medical Education and Research, Chandigarh  
Address  Department of Endocrinology, Post Graduate Institute of Medical Education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  ramawalia@rediffmail.com  
 
Source of Monetary or Material Support  
Biomedical Device and Technology Development (BDTD), DST India 
 
Primary Sponsor  
Name  Biomedical Device and Technology Development BDTD DST India 
Address  GOVERNMENT OF INDIA MINISTRY OF SCIENCE and TECHNOLOGY DEPARTMENT OF SCIENCE and TECHNOLOGY TECHNOLOGY BHAVAN, NEW MEHRAULI ROAD, NEW DELHI – 110 016 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
B J Madan Co   B J Madan & Co. Space No 2, 2nd Floor, C- 110/2, Naraina Industrial Area, Phase 1, Delhi 110028  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jaya Shukla  Post Graduate Institute of Medical Education and Research  Department of Nuclear Medicine Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh
Chandigarh
CHANDIGARH 
01722756724

shuklajaya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D093||Carcinoma in situ of thyroid and other endocrine glands,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  Not applicable No molecule is currently available globally, this ready to use formulation seems very promising. 68Ga-mDesmo PET/CT imaging will delineate the corticotropinoma from EAS without further performing invasive and costly test like BIPSS. It will also provide surgeons the requisite information for intra-operative tumor navigation 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with endogenous Cushing’s syndrome
2.Patients in the age group of 5 to 75 years.
3.Patients willing to give consent.
 
 
ExclusionCriteria 
Details  1.Patient with exogenous exposure to steroids
2.Ongoing pregnancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PET/CT imaging to provide functional as well as anatomical information for intra-operative tumor navigation and preservation of normal pituitary.   Single time point.
 
 
Secondary Outcome  
Outcome  TimePoints 
Diagnostic outcome will benefit in precision surgery of pitutiary micro-adenoma  Single point 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/08/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cushing’s syndrome (CS) is one of the most enigmatic endocrine disorders. It is important to confirm the ACTH dependent hypercortisolism and distinguishing Cushing’s disease from ectopic CS.  Most of the ACTH dependent CS are caused by Cushing’s disease, of which majority are due to microadenoma being less than 6 mm. Visualizing tumors within 10 mm pituitary and confirming its functional status is challenging. Long-term remission/cure is determined by the correct functional and anatomical delineation of corticotropinoma (pituitary-tumor). The treatment of choice in Cushing’s disease is pituitary microsurgery. However, pituitary-tumor is not well delineated within the sella in 30-40% using currently available investigations especially MRI and inferior petrosal sinus sampling, which affects intra-operative navigation for selective adenomectomy and influence remission rate.

Now we have developed a non-radioactive (cold kit) formulation. So that the same may be available to all hospital based radiopharmacy for quick and a facile synthesis of PET tracer, Ga-68 mDesmo, for lateralizing pituitary adenoma (Cushing’s disease) and differential diagnosis of ACTH-releasing pituitary adenoma (Cushing’s disease) from the of ectopic ACTH-secreting tumors by non-invasive molecular imaging (PET/CT).

 
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