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CTRI Number  CTRI/2025/02/080418 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Development of smartphone camera based microscopic system for intraoperative identification of parathyroid tissue in thyroid and parathyroid surgeries 
Scientific Title of Study   Development of TIRF based microscopic system with smartphone camera and probe based spectroscopic system as diagnostic tool for intraoperative identification of parathyroid tissue surgeries 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kamal Kataria 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Surgical Disciplines, AIIMS, DELHI
B5-51, THIRD FLOOR, SAFDARJUNG ENCLAVE, DELHI
South West
DELHI
110029
India 
Phone  9212678920  
Fax    
Email  drkamalkataria@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kamal Kataria 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Surgical Disciplines, AIIMS, DELHI
B5-51, THIRD FLOOR, SAFDARJUNG ENCLAVE, DELHI

DELHI
110029
India 
Phone  9212678920  
Fax    
Email  drkamalkataria@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kamal Kataria 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Surgical Disciplines, AIIMS, DELHI
B5-51, THIRD FLOOR, SAFDARJUNG ENCLAVE, DELHI

DELHI
110029
India 
Phone  9212678920  
Fax    
Email  drkamalkataria@gmail.com  
 
Source of Monetary or Material Support  
ICMR 
 
Primary Sponsor  
Name  ICMR 
Address  Ansari Nagar, Delhi, India - 110029 
Type of Sponsor  Government funding agency 
 
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 
Kamal Kataria  All India Institute of Medical Sciences, New Delhi  Room No 417, 4th Floor, Surgery BlockAnsari Nagar, AIIMS, Delhi - 110029
South West
DELHI 
9212678920

drkamalkataria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E210||Primary hyperparathyroidism, (2) ICD-10 Condition: E210||Primary hyperparathyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Identification of parathyroid gland based on autofluorescence with Near Infrared based system  Identification of parathyroid gland on the basis of autofluorescence with Near Infrared based system 
Comparator Agent  Use of near infrared System for identification of cervical Lymph node (acting as control)  Cervical lymph node dont have inherent autofluorescence like parathyroid so they will not be visible with near Infrared System 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients undergoing hemi/total thyroidectomy for thyroid disease
2. Patients undergoing parathyroidectomy for parathyroid disease
3. Age more than 18 and less than 70
 
 
ExclusionCriteria 
Details  1. Patients refusing to give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Design and development of TIRF based microscopic system with smartphone camera as a detector using 780 nm LED array.
2. Development and validation of NIR laser with fibre optic probe-based on auto-fluorescence spectroscopic system for intraoperative detection of parathyroid glands (PGs).
3. Comparison of the proposed method with existing methods in use
 
All above outcomes will be assessed during Surgery only 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the proposed method with existing methods in use
 
Three years 
 
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)   01/04/2025 
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="3"
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  

The primary aim of surgery in patients with well-differentiated thyroid cancer is complete removal of the tumor. However, preventing complications is as important as removal of the tumor because post-thyroidectomy complications such as permanent hypocalcemia due to inadvertent removal of parathyroid glands can be very painful to both surgeons and patients. Moreover, exact localization of parathyroid glands in hyperparathyroidism patients undergoing surgery is also difficult. There has been no reliable intraoperative method for detection of parathyroid gland(s) during thyroid and parathyroid surgeries. The intraoperative identification of parathyroid glands is challenging because of their small size, variable location, and ambiguous shape as well. Thus, the solution has been mostly based on intuitive visual inspection which can be gained through extensive surgeon experience. However, precise identification and preservation of parathyroid glands can be difficult even for highly skilled surgeons under some situations, such as distorted anatomy from previous surgery, intrathyroidal location, presence of ectopic or super-numerous glands, extensive tumor invasion. To avoid these complications, several techniques such as frozen biopsy, fine needle aspiration (FNA) and parathyroid hormone (PTH) assay, methylene blue staining or indocyanine green (ICG) injection, have been introduced but they showed limited roles in localizing parathyroid glands during thyroidectomy. Since methylene blue and ICG are associated with various side effects, sometimes very severe one, so there is need to find a method, which is cheap and require no use of exogenous fluorophores. Such solution is seen with use of parathyroid’s autofluorescence for intraoperative detection.

      Autofluorescence signal of parathyroid gland is difficult to be detected by naked eye but a NIR (Near Infrared) fluorescence imaging system is required to detect this signal. Autofluorescence, or native fluorescence, is a phenomenon that consists of the emission of fluorescence light in a slightly longer spectral range when the biological substrates are excited with light at suitable wavelengths. It has been found that the parathyroid and thyroid glands emit light at a wavelength of 820 nm when illuminated with light around 785 nm wavelength respectively but parathyroid gland has significantly higher autofluorescence as compared to surrounding structures in the neck, regardless of healthy or diseased states. So far, studies on NIR wavelengths that are attractive in biomedicine and clinical applications have mainly been performed by administrating ICG. ICG is an exogenous contrast, which has been widely used as a non-specific agent for the localization of diseased parathyroid glands.

 
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