Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Indocyanine green dye based sentinel node mapping: In the cases with suspected epithelial ovarian cancer, sentinel lymph node (SLN) mapping will be performed using indocyanine green (
Sponsors
All India Institute of Medical Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Women aged more than eighteen years Women with suspected/Histologically confirmed (frozen section acceptable) stage I-II epithelial ovarian/tubal/peritoneal carcinoma undergoing primary staging No radiologically suspicious nodes (short-axis less than ten mm and no malignant morphology). Able to provide written informed consent
Exclusion criteria
Exclusion criteria: Intra-operative finding of carcinomatosis/extra-ovarian disease before SLN injection (Stage IIIC /IV disease) Previous surgery on one or both ovaries Prior h/o cytoreductive surgery or neoadjuvant chemotherapy or recurrent disease Presence of bulky nodes (more than two cm) Non-epithelial histologies Known allergy to ICG/iodine or prior anaphylaxis to contrast dyes. Previous history of RT for any malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Detection rate parameters: Number of patients in whom at least one sentinel lymph node (SLN) is detected (per-patient detection rate) Number of nodal fields in which sentinel lymph nodes are detected (per-nodal field detection rate) Number of cases with mapping failure (no SLN detected) Timepoint: Assessed intraoperatively at the time of sentinel lymph node mapping during primary surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Assessment of laterality & anatomical distribution of SLNs 3. Time from ICG injection to SLN identification. 4. Proportion of SLNs with isolated tumor cells, micrometastases, or macrometastases on ultrastaging 5. Diagnostic accuracy parameters: Number of nodes identified with tumor deposits in both sentinel lymph nodes (SLNs) & lymphadenectomy specimens (True Positive). Number of nodes identified without tumor deposits in both SLNs & lymphadenectomy specimens (True Negative). Number of nodes identified without tumor deposits in SLNs but with tumor deposits in lymphadenectomy specimens (False Negative). 6. Concordance between fluorescence signal detected LN & histopathology assessment 7. Number of patients developing procedure-related adverse events (graded by CTCAE v6.0) 8. Rate of empty packets Timepoint: Assessment of laterality & anatomical distribution of SLNs Intraoperative; Time from ICG injection to SLN identification Intraoperative; Proportion of SLNs with isolated tumor cells/micro- or macrometastases on ultrastaging within 2 weeks; Diagnostic accuracy parameters within 2 weeks; Concordance between fluorescence-detected LN & histopathology within 2 weeks; Procedure-related adverse events up to 30 days; Rate of empty packets within 2 weeks. | — |
Countries
India
Contacts
Public ContactShagun Kapoor
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed