| CTRI Number |
CTRI/2025/06/089329 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Using Light and Sound Technology to Detect Normal and Cancerous Colon Tissues |
|
Scientific Title of Study
|
Detecting normal benign and malignant colonic tissues by photoacoustic spectroscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Kishore Mahato |
| Designation |
Professor |
| Affiliation |
Manipal School of Life Sciences, Manipal Academy of Higher Education |
| Address |
Department of Biophysics, Manipal School of Life Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9448836553 |
| Fax |
|
| Email |
kkmahato@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishna Kishore Mahato |
| Designation |
Professor |
| Affiliation |
Manipal School of Life Sciences, Manipal Academy of Higher Education |
| Address |
Department of Biophysics, Manipal School of Life Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9448836553 |
| Fax |
|
| Email |
kkmahato@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Kishore Mahato |
| Designation |
Professor |
| Affiliation |
Manipal School of Life Sciences, Manipal Academy of Higher Education |
| Address |
Department of Biophysics, Manipal School of Life Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9448836553 |
| Fax |
|
| Email |
kkmahato@gmail.com |
|
|
Source of Monetary or Material Support
|
| DBT-BUILDER, Govt. of India, Block 3 CGO Complex, Lodhi Road, New Delhi - 110 003, India |
|
|
Primary Sponsor
|
| Name |
DBT-BUILDER, Govt. of India |
| Address |
6th-8th Floor, Block 2 and 4th-5th Floor, Block 3 CGO Complex, Lodhi Road New Delhi - 110 003.India |
| 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 |
| Dr K K Mahato |
Manipal School of Life Sciences |
4th Floor, High Power Nd-YAG Laboratory, Department of Biophysics
Udupi
KARNATAKA |
9448836553
kkmahato@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (2) ICD-10 Condition: C20||Malignant neoplasm of rectum, (3) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Histopathological classification |
As a comparator, histopathological classification will be used as the gold standard for validation. Tissue samples collected from patients undergoing colonoscopy or surgery will be classified as normal, benign, or malignant based on histopathological examination. The PA probes diagnostic performance will be assessed by comparing its classification results with those obtained from histopathology. Since histopathology remains the standard method for diagnosing colonic pathologies, this comparison will help determine the reliability and accuracy of PA spectroscopy as a potential diagnostic tool for colonic tissue characterization. |
| Intervention |
Photoacoustic Spectroscopy |
Photoacoustic Spectroscopy (PAS) is a laser-based imaging technique that analyzes tissue absorption and acoustic signals to differentiate normal, benign, and malignant colonic tissues. In this study, PAS will be used for ex vivo analysis of collected tissue samples, aiming to identify unique spectral signatures for diagnosis. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults above the age of 18 years
Patients undergoing colonoscopy for any clinical indication
Patients undergoing surgical removal of part of the colon for any clinical indication |
|
| ExclusionCriteria |
| Details |
Patients are not able to give consent.
Emergency colonoscopy procedures.
Hemodynamically unstable patients.
Patients with serious comorbid illnesses preventing full colonoscopy from being performed. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The newly developed photoacoustic endoscopic probe can classify different
tissue pathological conditions in colorectal mucosa by utilizing the distinct optical absorption properties
of biomarkers such as collagen, NADH, elastin, and FAD. These biomarkers allow the probe to
distinguish between normal, adenomatous, and carcinomatous tissues. Integrating machine learning
into the system further enhances diagnostic accuracy by recognizing complex patterns in the spectral
data, offering a non-invasive, real-time tool for early detection and improved treatment of colorectal
cancer. |
Three years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study has the potential for translation into clinical practice. |
5 years |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
07/07/2025 |
| 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="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 development of a photoacoustic probe for detecting colonic mucosal conditions is a
significant advancement in the diagnosis and treatment of colorectal cancer. This innovative
technology aims to offer a quick and real-time method for identifying cancerous tissues. It
addresses the limitations of conventional colonoscopy, which only allows for visual inspection
without the ability to distinguish between different mucosal conditions like adenoma and
carcinoma. The photoacoustic probe uses the unique optical absorption properties of tissue
components such as collagen, NADH, elastin, and FAD, which can serve as biomarkers for
cancer diagnosis. By detecting the specific spectral patterns of these biomarkers, the probe can
accurately identify and differentiate between normal, adenomatous, and carcinomatous tissues.
To improve the diagnostic capabilities of this technology, we will develop a machine-learning
model. This model will be trained using spectral data obtained from the photoacoustic probe,
enabling it to recognize complex patterns associated with different colonic mucosal conditions.
Integrating machine learning will not only enhance the accuracy and reliability of the diagnosis
but also aid in the development of a highly sensitive and specific diagnostic tool. This approach
has the potential to revolutionize colorectal cancer screening by providing a non-invasive, realtime diagnostic method that can lead to early detection and timely treatment, thus improving
patient outcomes and reducing the burden of colorectal cancer. The proposed study has the potential to significantly improve cancer diagnosis and treatment.
It involves developing a photoacoustic probe specifically for detecting conditions in the colon’s
mucosal lining. This technology can be seamlessly integrated into existing endoscopy and
colonoscopy procedures, allowing for real-time, accurate diagnosis of colorectal cancers during
routine examinations. This can greatly improve the speed and efficiency of cancer detection
compared to traditional methods that rely on biopsy and histopathology, which can be timeconsuming and may delay treatment. The photoacoustic probe provides immediate results,
enabling healthcare providers to make informed decisions on the spot. This real-time diagnostic
capability can lead to earlier detection of malignant tissues, more precise characterization of
mucosal abnormalities, and timely intervention, ultimately enhancing patient outcomes. The
clinical translation of this technology represents a significant advancement in colorectal cancer
screening and diagnosis, potentially setting a new standard in gastroenterological practice. |