INDOCYANINE GREEN for Cervical cancer | Vulvar cancer | Vaginal cancer | Endometrial cancer

Inclusion criteria

• {"criterion_text":"- Age ≥18 years, and < 75 years"}
• {"criterion_text":"- Cervical/vulvar/vaginal/endometrial cancer recurrence/progression or persistence suitable for pelvic exenteration histologically confirmed"}
• {"criterion_text":"- Estimated life expectancy of at least 4 weeks"}
• {"criterion_text":"- Signed written informed consent"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to indocyanine green, to sodium iodide or to iodine"}
• {"criterion_text":"- Subjects who are employed by or otherwise dependent on the sponsor or the investigator may not be enrolled in the study"}
• {"criterion_text":"- Patients affected by hyperthyroidism, or with autoimmune thyroid adenomas"}
• {"criterion_text":"- Severe kidney failure (eGFR <30ml/min/1,73m2)"}
• {"criterion_text":"- Patients undergoing only posterior pelvic exenteration"}
• {"criterion_text":"- Patients undergoing ureterostomy"}
• {"criterion_text":"- Patients who underwent previous ureteral surgery (open, endoscopic or minimally invasive)"}
• {"criterion_text":"- Refusal to sign written informed consent"}
• {"criterion_text":"- Any clinical condition, which in the opinion of the investigator, places the subject at risk, prevents the subject from fully participating in the trial procedures, or potentially impairs the quality of the trial data"}
• {"criterion_text":"- Participation in a clinical study in which an investigational drug was administered within 30 days or 5 half-lives before the ICG administration, whichever is longer"}

Primary endpoints

• {"endpoint_text":"- the overall rate of benign uretero-enteric stricture","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Rate of Clavien Dindo grade three and four post-operative complications, both early (within 30 days after surgery) and late (from day 31 to day 180 after surgery)","definition_or_measurement_approach":"Post-operative complications graded by Clavien-Dindo classification; measured in specified time windows: early (within 30 days) and late (day 31 to day 180)."}
• {"endpoint_text":"- To assess the overall rate of ureteric leak in the study sample","definition_or_measurement_approach":""}
• {"endpoint_text":"- To assess the differences in eGFR (i.e., renal function) over time (baseline, 1, 3 and 6 months) according to fluorescence levels","definition_or_measurement_approach":"Renal function assessed by eGFR at baseline, 1, 3 and 6 months and compared according to fluorescence levels."}
• {"endpoint_text":"- To assess 12-months overall survival (OS) and progression free survival (PFS)","definition_or_measurement_approach":"Overall survival (OS) and progression-free survival (PFS) assessed at 12 months."}

Italy

Earliest CTIS Part Ii Submission Date

07-10-2024

Latest Decision Or Authorization Date

25-11-2024

Processing Time Days

49

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy