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CTRI Number  CTRI/2025/04/084939 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Screening 
Study Design  Single Arm Study 
Public Title of Study   Opto-electrical Transvaginal imaging probe for cervical pre-cancer diagnosis 
Scientific Title of Study   Opto-electrical transvaginal imaging probe for preinvasive cervical cancer diagnosis. 
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 Arpitha A 
Designation  Associate Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dept of OG, WCH building, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India 
Phone  9481068681  
Fax    
Email  drarpithagynonco@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arpitha A 
Designation  Associate Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dept of OG, WCH building, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India 
Phone  9481068681  
Fax    
Email  drarpithagynonco@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arpitha A 
Designation  Associate Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dept of OG, WCH building, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India 
Phone  9481068681  
Fax    
Email  drarpithagynonco@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research,Jipmer Campus Rd, Jipmer Campus, Puducherry-605006,INDIA  
 
Primary Sponsor  
Name  ICMR 
Address  ICMR, V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Research institution 
 
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 
Dr Arpitha Anantharaju  Jawaharlal Institute of Postgraduate Medical Education and Research  Room No:13,Department of Obstetrics and Gynaecology
Pondicherry
PONDICHERRY 
9481068681

drarpithagynonco@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy females screened for pre cancer lesions and found positive by one of the screening methods. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Agreeement of opto electric probe high grade lesion with the colposcopic high grade lesion (Swede Score 5)  Agreeement of opto electric probe high grade lesion with the colposcopic high grade lesion (Swede Score 5) Duration:2 years 
Comparator Agent  Agreement of high grade lesion of opto electric probe with high-grade histopathogy impression  Agreement of high grade lesion of opto electric probe with high-grade histopathogy impression Duration 2 Years 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  1. Age: Above 18 years and up to 75 years
2. Female OPD patients
3. Screen positive patients coming for colposcopy
Having any one of the following:
a. Pap smear- ASCUS, ASCUS H, LSIL, HSIL
b. VIA/VILI Abnormal report
c. HPV DNA positive

 
 
ExclusionCriteria 
Details  1. Post hysterectomy
2. Menstruating at the time of visit
3. Pregnant at the time of visit
4. Active cervicitis or vulvovaginitis
5. Obvious growth in cervix suggestive of cancer
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To see the agreement of opto-electric bimodal transvagi-nal imaging probe to detect high grade lesions with colpo-scopic high grade lesion (Swede colposcopy index more than 5).
2.To determine the diagnostic accuracy of bimodal trans-vaginal multispectral imaging probe in comparison to standard coposcopy to detect premalignant lesions (CIN2 or CIN3 - pathology). 
The opto-electric probe will freeze by 12 weeks and the recruitment will start from 1st July, 2025. 
 
Secondary Outcome  
Outcome  TimePoints 
Find the sensitivity and specificity of the opto-electric probe to detect preinvasive cervical lesion.  Within 6 months of the completion of the first phase of the trial.  
 
Target Sample Size   Total Sample Size="410"
Sample Size from India="410" 
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)   01/06/2025 
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 Applicable 
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  

Background: Cervical cancer is the fourth highest cause of mortality around the world. However, cervical cancer progression is slow, and takes about ten years before fully developing. The current techniques, such as cytology which gives very high accuracy, are costly and requires highly skilled workforce. The colposcopy used as triage to locate the high-grade lesion involves using acetic acid, which is corrosive, resulting in patients’ pain during the procedure and needs an expert pathologist to interpret the colposcopy guided biopsies. Recommended screening with HPV DNA is far-fetched due to the cost.

Scientific Rationale: Due to the reduced activity of the ferrochelatase enzyme during the heme cycle, there is a buildup of porphyrin and lower total haemoglobin within the cancer cells. The proposed transvaginal probe estimates the cancer biomarkers, such as protein, glycogen, PpIX, HbO2, and Hb, on the tissue surfaces to differentiate the cancerous tissues from adjacent normal. The proposed transvaginal imaging probe uses autofluorescence and multispectral diffuse reflectance spectroscopy modalities to do so. The probe detects the increase in porphyrin by shining the light at 405 nm and detecting the image from the tissue surface at about 540 nm. The probe also houses LEDs operating at 545 nm and 575 nm to target the two isosbestic points for HbO2 and Hb and 610 nm, where the absorption coefficient of Hb is about ten times more than HbO2. The camera captures images of the tissue surface by shining the light with 545 nm, 575 nm, and 610 nm, one after the other. The ratio R610/R545, R610/R575, and autofluorescence differentiate the cancerous region from the adjacent normal tissues.

Moreover, the cervical epithelium is a structured tissue undergoing significant changes as it advances from normal epithelium to high-grade Cervical Intraepithelial Neoplasia (CIN). These changes involve a decrease in stratification, an increase in the nuclear-cytoplasmic ratio, and an increase in the extracellular space. Electrical impedance spectroscopy (EIS) has been used as an adjunct to colposcopy for cervical cancer diagnosis for many years. Also, based on the prior work by Prof. Pandya’s lab at IISc, it was found that electrical impedance and associated electrical analogy model parameters can be potentially used for tumour diagnosis and delineation. Electrical impedance tomography (EIT) is a non-invasive imaging method that uses low-frequency electrical signals to produce images of the electrical properties of tissues within a body. Although the EIT approach has existed for nearly two decades, the application of EIT has been limited due to the challenges in the positioning of electrodes and modelling the electrode location, low resolution, and inaccuracy of the images for imaging tissue regions far from the electrodes. The proposed transvaginal imaging probe incorporates a novel approach of EIT with a unique combination of electrode design and electronic data acquisition unit that enables miniaturization into the size of a probe

Novelty and Indigenization:

• The novelty of this project is the application of bi-modal (optical and electrical) for diagnosis of preinvasive lesions in cervix.

• The label-free transvaginal imaging probe housing multiple narrow bandwidth LEDs, subminiaturized high-resolution CMOS camera, and the development of the electronic chip to perform diffused reflectance imaging and electrical impedance tomography is to be indigenously fabricated in the lab.

Expected Outcome:

The objective of the project is to design and develop an at-community digitally connected imaging probe which can be used to capture images of the cervix and share with the clinician in remote location using WiFi or mobile internet. The images can yield rapid assessment with the help of Artificial Intelligence (AI) in identifying preinvasive cancer.

We expect the probe to identify the high-grade lesion with diagnostic accuracy as good as standard colposcopy performed by the physician. With this expectation we can in future offer point of care screen and treat at community.

 
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