| CTRI Number |
CTRI/2026/04/109215 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
23/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Radiomic study |
| Study Design |
Other |
|
Public Title of Study
|
A Study Using Artificial Intelligence to Predict Treatment Success and Survival in Patients with Rectal, Pancreatic, and Liver Cancers |
|
Scientific Title of Study
|
Artificial Intelligence and Its clinical Relevance in Gastrointestinal Malignancies: A Comprehensive Study on Rectal, Pancreatic, and Liver Cancer imaging Data. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
REENA ENGINEER |
| Designation |
Professor |
| Affiliation |
TATA MEMORIAL HOSPITAL, MUMBAI |
| Address |
Department of Radiation Oncology, Room No. 1122, 11th Floor, Homi Bhabha Building, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India - 400012.
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820128662 |
| Fax |
|
| Email |
reena.engineer@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
REENA ENGINEER |
| Designation |
Professor |
| Affiliation |
TATA MEMORIAL HOSPITAL, MUMBAI |
| Address |
Department of Radiation Oncology, Room No. 1122, 11th Floor, Homi Bhabha Building, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India - 400012.
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820128662 |
| Fax |
|
| Email |
reena.engineer@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
REENA ENGINEER |
| Designation |
Professor |
| Affiliation |
TATA MEMORIAL HOSPITAL, MUMBAI |
| Address |
Department of Radiation Oncology, Room No. 1122, 11th Floor, Homi Bhabha Building, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India - 400012.
Mumbai MAHARASHTRA 400012 India |
| Phone |
9820128662 |
| Fax |
|
| Email |
reena.engineer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Dr. Ernest Borges Marg, Parel, Mumbai, Maharashtra, India - 400012. |
|
|
Primary Sponsor
|
| Name |
Dr. Reena Engineer |
| Address |
Tata Memorial Hospital , Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Reena Engineer |
TATA MEMORIAL HOSPITAL, MUMBAI |
Department of Radiation Oncology, Room No. 1122, 11th Floor, Homi Bhabha Building, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India - 400012. Mumbai MAHARASHTRA |
9820128662
reena.engineer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - I , Tata Memorial Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C229||Malignant neoplasm of liver, not specified as primary or secondary, (2) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (3) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and older.
2. Patients registered at Tata Memorial Hospital as outpatients between 2015 and 2022.
3. Confirmed diagnosis of rectal carcinoma.
4. Confirmed diagnosis of pancreatic carcinoma classified as borderline resectable (BRPC) or locally advanced (LAPC).
5. Confirmed diagnosis of hepatocellular carcinoma (liver cancer).
6. Patients who have undergone neoadjuvant chemoradiotherapy for rectal cancer.
7. Patients who have received stereotactic body radiation therapy (SBRT) for pancreatic cancer.
8. Patients who have received SBRT and systemic therapy for liver cancer.
9. Availability of baseline imaging data (CT or MRI) and digitized pathology slides on the Picture Archiving and Communication System (PACS) in DICOM format |
|
| ExclusionCriteria |
| Details |
1)Non availability of online DICOM images.
2)Non availability of clinical data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of the AI model in predicting "Radiological Response" and treatment success in gastrointestinal cancer patients |
At the time of post-treatment or final clinical assessment (typically 6 to 12 weeks after completion of chemoradiotherapy). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiomic feature reproducibility (ICC/CCC) |
During the feature extraction phase (at study baseline analysis) |
| Overall Survival (OS) defined as the time from the start of treatment to death from any cause |
At 1 years & 3 years post-treatment. |
| Progression-Free Survival (PFS) defined as the time from the start of treatment to disease progression or death. |
At 1 years & 3 years post-treatment. |
|
|
Target Sample Size
|
Total Sample Size="750" Sample Size from India="750"
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)
|
16/09/2026 |
| 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="2" 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
|
This study uses artificial intelligence (AI) to improve the treatment of rectal, pancreatic, and liver cancers. By analyzing medical images like CT scans, MRIs, PET scans and digitised pathology slides AI can help doctors understand how tumors are responding to treatment and predict future outcomes. This approach aims to make cancer treatment more personalized, allowing doctors to choose the most effective treatment plan for each patient. Currently, predicting how well a patient will respond to cancer treatments is difficult, as there are no reliable tests for this. This study will create AI tools that can predict which patients will respond well to treatment, which might need a different approach, and how long they are likely to survive or stay cancer-free. The study will analyze medical images from all TMC hospital to develop these tools and improve decision-making in cancer care. We (TMH) will be providing imaging data of pancreatic , hepatic and rectal malignancies to Dr Satish Viswanath Associate Professor, Emory University, Atlanta,. Emory University will run specialised software for radiomic feature extraction . We will use these radiomic feature for clinical correlation . The main goal of this study is to use AI to provide more accurate predictions and help doctors make better treatment decisions. By training AI to predict treatment responses, survival chances, and the effectiveness of different therapies, the researchers hope to improve cancer outcomes. This personalized approach could lead to better survival rates, fewer unnecessary treatments, and an overall improvement in the quality of care for cancer patients. |