| 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
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Ansari Nagar, Delhi, India - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| 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
|
|
|
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. |