| CTRI Number |
CTRI/2025/03/081497 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking the practicality and safety to identify lymphnodes in patients undergoing surgery for early uterine cancer using special dye and hand held camera- A study from tertiary center |
|
Scientific Title of Study
|
Feasibility, sensitivity and detection rate of Sentinel Lymph Node Mapping
Using hand-held NIR Fluorescence camera with ICG in Early Stage
Endometrial Cancer: A pilot study from a tertiary cancer care Center. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amy Jose |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute(WIA) Adyar |
| Address |
Department of Gynaecologic Oncology
Cancer Institute (WIA)
Adyar
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
9445586032 |
| Fax |
|
| Email |
JOSE.AMY@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Amy Jose |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute(WIA) Adyar |
| Address |
Department of Gynaecologic Oncology
Cancer Institute (WIA)
Adyar
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
9445586032 |
| Fax |
|
| Email |
JOSE.AMY@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Amy Jose |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute(WIA) Adyar |
| Address |
Department of Gynaecologic Oncology
Cancer Institute (WIA)
Adyar
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
9445586032 |
| Fax |
|
| Email |
JOSE.AMY@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Cancer Institute (WIA), Sardar Patel Road, Adyar, Chennai, Tamil Nadu, India. PIN - 600020 |
|
|
Primary Sponsor
|
| Name |
Dr Amy Jose Primary Investigator |
| Address |
Assistant professor, Department of Gynaecologic Oncology
Cancer Institute (WIA), Sardar Patel Road, Adyar, Chennai, Tamil Nadu, India. PIN - 600020 |
| 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 Amy Jose |
cancer Institute (WIA), Adyar |
Surgical Theater, Department of Gynaecologic Oncology, cancer Institute (WIA)
Sardar Patel Road
Adyar
Chennai
Chennai
TAMIL NADU |
9445586032
jose.amy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CANCER INSTITUTE (WIA), EC-CT-2020-0141 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C541||Malignant neoplasm of endometrium, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Uterine cervical injection of ICG dye in all stages of early endometrial carcinoma. plan to carry out as single arm study. |
study is to assess the rate of sentinel node mapping and is planned as a single arm study and no comparison is made. Dye will be injected during surgery after laparotomy incision.
Irrespective of the sentinel node detection rate, the adequate staging procedure including the complete nodal dissection will be done . This is planned to carry out for first 20 cases undergoing surgery. |
| Intervention |
Uterine cervical injection of ICG dye in all stages of early endometrial carcinoma |
study is to assess the rate of sentinel node mapping and is planned as a single arm study and no comparison is made. Dye will be injected during surgery after laparotomy incision.
Irrespective of the sentinel node detection rate, the adequate staging procedure including the complete nodal dissection will be done . This is planned to carry out for first 20 cases undergoing surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Biopsy confirmed endometrial carcinoma patients with any histology and grade
2. Clinical and radiological (CT/MRI abdomen and pelvis or whole body PET Ct) early stage endometrial carcinoma undergoing staging laparotomy
3. Willingness to be part of the trial |
|
| ExclusionCriteria |
| Details |
Extra uterine disease or those who received neoadjuvant radiation/ chemotherapy for the present disease or those with previous h/o pelvic irradiation or pelvic node dissection for any cause |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary
1. Evaluation o feasibility of open ICG fluorescent injection technique for SLN mapping in carcinoma endometrium
2. To detect the sensitivity and specificity, positive and negative predictive values of open SLN testing in carcinoma endometrium.
Secondary Objective- To analyse the detection rate- unilateral, bilateral and sites of detection |
Study is planned to carry out in first 20 cases of carcinoma endometrium undergoing laparotomy surgery. All outcomes are measured at single point, during surgery and at the final pathological confirmation
Day 0, 3 weeks post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Objective- To analyse the detection rate- unilateral, bilateral & sites of detection |
Study is planned to carry out in first 20 cases of carcinoma endometrium undergoing
laparotomy surgery. All outcomes are measured at single point, during surgery & at the final pathological confirmation.
Day 0 & at 3 weeks post surgery |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/03/2025 |
| 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="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
|
Significant advances in the surgical management of endometrial cancer are the safe adoption of minimally invasive surgery and the use of sentinel lymph node(SLN) mapping through fluorescence-guided minimally invasive surgery. Several trials comparing the accuracy of SLN, lymphadenectomy or SNL plus lymphadenectomy have confirmed that SLN is not inferior in identifying nodal disease.Blue dye, radiotracer 99mTc and Indocyanine green dye (ICG) are commonly explored in endometrial cancer, and now, recently, sentinel node mapping using indocyanine green is much assuring.Blue dye is associated with allergic reactions, and radiolabelled tracer is related to many logistic challenges and costs despite better detection rates. ICG dye is a fluorescent dye approved by the FDA. It can be lighted with near-infrared fluorescent light and is extensively used in intra-operative imaging for better anatomic and functional information. Our institute has recently acquired the IRILIC NIR handheld camera, which can be used intra-operatively in open surgery.
Study Method Prospective, open-labeled, non-randomized exploratory intervention trial
The organisation of work elements Written informed consent will be obtained from patients who fulfil the inclusion criteria and are willing to participate in the study.
Intraoperative assessment After anaesthesia, a laparotomy incision will be made midline vertical. After entry into the peritoneal cavity, peritoneal wash cytology will be taken. A thorough assessment of abdominal activity will be conducted to rule out any significant lymph nodes or gross extrauterine disease. SLN mapping will be started after ruling out extrauterine disease.
SLN Mapping 1. Intra-cervical injection of ICG at 3 and 9 o’clock positions at concentrations of 1.25mg/ml, submucosally(2-3mm) and deep 1 cm into the stroma, one ml per injection site. One vial of AUROGREEN ( ICG powder 25mg) will be constituted with 20 ml of sterile water to obtain the concentration. 2. Post injection, room lights are switched off to obtain a dark operating room and almost immediately, the pelvic spaces will be opened to do sentinel mapping using the hand-held NIR camera. 3. The sentinel nodes are those identified in proximity to the uterus lighted up in fluorescent green colour on the NIR camera. 4. Only lymphatic channels draining to a node are seen, and if the node is not lightened up, it can also be considered a sentinel node. 5. Detected nodes will be sent for a staging procedure in the final histopathological examination with ultra staging. 6. As this is planned as a pilot study, after SLN mapping, irrespective of the dye uptake, routine lymphadenectomy as indicated for the histology, grade, and stage will be done, including pelvic and para-aortic lymphadenectomy.
Schedule After the approval, 20 consecutive cases of carcinoma endometrium fulfilling the selection criteria and undergoing staging laparotomy will be recruited for the present study. |