| CTRI Number |
CTRI/2025/10/096027 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Using AI to Predict if Stomach or Ovarian Cancer Will Spread to the Abdomen Before Surgery"
|
|
Scientific Title of Study
|
AI-Driven prediction of Occult Peritoneal Metastases using Pre-operative Clinical and CT data in Gastrointestinal and Gynaecological cancers. |
| 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 Preethi S Shetty |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Surgical Oncology
Shirdi Sai Cancer Block
Kasturba Medical College
Madhav Nagar
Udupi KARNATAKA 576104 India |
| Phone |
9567060979 |
| Fax |
|
| Email |
preethi.sshetty@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Preethi S Shetty |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Surgical Oncology
Shirdi Sai Cancer Block
Kasturba Medical College
Madhav Nagar
Udupi KARNATAKA 576104 India |
| Phone |
9567060979 |
| Fax |
|
| Email |
preethi.sshetty@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Preethi S Shetty |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Surgical Oncology
Shirdi Sai Cancer Block
Kasturba Medical College
Madhav Nagar
Udupi KARNATAKA 576104 India |
| Phone |
9567060979 |
| Fax |
|
| Email |
preethi.sshetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
V. Ramalingaswami Bhawan, P.O. Box No. 4911 · Ansari Nagar, New Delhi - 110029, India · Ph: 91-11-26588895 |
|
|
Primary Sponsor
|
| Name |
ICMRDHR |
| Address |
Indian Council of Medical Research · V. Ramalingaswami Bhawan, P.O. Box No. 4911 · Ansari Nagar, New Delhi - 110029, India · Ph: 91-11-26588895 |
| 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 Preethi S Shetty |
Kasturba Medical College |
Department of Surgical Oncology
Shirdi Sai Cancer Block
Madhav Nagar, Manipal Udupi KARNATAKA |
9567060979
preethi.sshetty@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee, IEC Secretariat, Room No. 22, Ground Floor, Faculty Room Complex, Kasturba Medical College Premises, Kasturba Medical College, Manipal - 576104, Karnataka, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C162||Malignant neoplasm of body of stomach, (2) ICD-10 Condition: C161||Malignant neoplasm of fundus of stomach, (3) ICD-10 Condition: C562||Malignant neoplasm of left ovary, (4) ICD-10 Condition: C163||Malignant neoplasm of pyloric antrum, (5) ICD-10 Condition: C164||Malignant neoplasm of pylorus, (6) ICD-10 Condition: C561||Malignant neoplasm of right ovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Locally advanced adenocarcinoma stomach patients who have undergone staging laparoscopy (SL) or laparotomy and have been found to have occult peritoneal metastases.
2) Locally advanced serous ovarian carcinoma patients who have undergone laparotomy and are found to have occult peritoneal metastases.
3) All the above patients have had a pre-operative CT scan done in the hospital within 4 weeks prior to the surgery
|
|
| ExclusionCriteria |
| Details |
1) Patients undergoing surgery for gastric malignancy other than adenocarcinoma, such as neuroendocrine tumors, gastrointestinal stromal tumors.
2) Patients undergoing surgery for ovarian malignancy other than serous ovarian carcinoma, such as benign pathology, early serous carcinoma, mucinous carcinoma, or clear cell carcinoma.
3) Patients who do not have pre-operative CT imaging available for analysis, or the CT is not of diagnostic quality.
4) Patients whose CT was done more than 1 month prior to the surgery.
4) Patients whose intraoperative notes do not contain any details about peritoneal findings.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prediction of occult peritoneal metastases from gastric and ovarian cancer using Artificial intelligence/deep learning based model on CT scan. |
4 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prediction of occult peritoneal metastases from gastric and ovarian cancer using combined clinical and deep learning CT based model. |
4.5 years |
|
|
Target Sample Size
|
Total Sample Size="765" Sample Size from India="765"
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)
|
01/11/2025 |
| 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="4" Months="6" Days="15" |
|
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
|
Introduction: According to GLOBOCAN 2022, in the year 2022, there were 968,000 new cases of gastric cancer and close to 660,000 deaths, ranking gastric cancer as fifth in terms of both incidence and mortality worldwide, while ovarian carcinoma had 324,398 new cases and 206,839 deaths worldwide, making it the 8th most common cancer with respect to incidence and mortality among women. In India, 10056 new cases of gastric cancer were registered between 2012 and 2016, and thus it ranks second amongst the gastrointestinal cancers. The presence of occult peritoneal metastases (PM) is currently difficult to diagnose in pre-operative radiological images, and many patients are found to have these metastases as a surprise finding during their elective surgery. This, thus, often results in abandoning a curative surgery for several reasons, such as the absence of adequate instruments or machinery for hyperthermic intra-peritoneal chemotherapy (HIPEC), or the patient might not be clinically fit for the extensive procedure, which would typically last for a minimum of 10 hours. Also, it adds to undue stress on the patient and the caretakers, especially since the patient is now termed as “metastatic” or “Stage IV” in layman’s terms. Moreover, if the presence of PM were to be detected preoperatively, the patient could have been adequately prepared for a successful cytoreductive surgery (CRS). This would then drastically improve the survival outcomes. With the advent of artificial intelligence (AI) and deep learning (DL) in healthcare, especially in radiology, the accuracy of preoperative diagnosis has now improved in breast and brain tumors. The use of AI and DL in gastrointestinal tumors and gynecological malignancies is still in its infancy. The DL approach is a novel method for image-based determination of complex relationships and has exhibited sophisticated performance for small feature detection and characterization. However, there is still a lack of integration of these radiological images with the intraoperative images. By having such a collaborative picture, the surgical outcomes can be improved. Methodology: A cross-sectional analysis of patients admitted with gastric adenocarcinoma and serous ovarian carcinoma and detected to have occult PM on staging laparoscopy or laparotomy will be performed. The patient’s clinical data and pre-operative CT imaging performed within four weeks of surgery will be obtained. The CT images will be segmentated manually for the primary and the peritoneum. The data will then be split randomly into training and test datasets using a 4:1 ratio. Using these CT images, radiomic signatures will be extracted using DL methods, and a radiomic feature set will be developed from the training cohort. The AI and DL model thus developed will be validated on the internal and external testing cohorts. Similarly, a clinical model will be developed and will be integrated with the AI/DL based CT model to produce a comprehensive model. Conclusion: The AI/DL model thus developed will be able to predict the occult peritoneal metastases on pre-operative imaging, avoiding unnecessary surgeries and/or providing personalised surgical planning. |