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Indocyanine green to assess vascularity of ileal conduit anastomosis and regulate ureteral resection margins during pelvic exenteration for recurrent/persistent gynecological cancer. A pilot study
EU CTIS ID: 2024-518783-13-00
What this study is testing
to assess the vascularity of ileal conduit UD in patients undergoing ICG perfusion-modulated resection of ureters undergoing ileal conduit
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years, and < 75 years
- Cervical/vulvar/vaginal/endometrial cancer recurrence/progression or persistence suitable for pelvic exenteration histologically confirmed
- Estimated life expectancy of at least 4 weeks
- Signed written informed consent
You likely can't join if
- Hypersensitivity to indocyanine green, to sodium iodide or to iodine
- Subjects who are employed by or otherwise dependent on the sponsor or the investigator may not be enrolled in the study
- Patients affected by hyperthyroidism, or with autoimmune thyroid adenomas
- Severe kidney failure (eGFR <30ml/min/1,73m2)
- Patients undergoing only posterior pelvic exenteration
- Patients undergoing ureterostomy
See the full eligibility criteria
- Age ≥18 years, and < 75 years
- Cervical/vulvar/vaginal/endometrial cancer recurrence/progression or persistence suitable for pelvic exenteration histologically confirmed
- Estimated life expectancy of at least 4 weeks
- Signed written informed consent
- Hypersensitivity to indocyanine green, to sodium iodide or to iodine
- Subjects who are employed by or otherwise dependent on the sponsor or the investigator may not be enrolled in the study
- Patients affected by hyperthyroidism, or with autoimmune thyroid adenomas
- Severe kidney failure (eGFR <30ml/min/1,73m2)
- Patients undergoing only posterior pelvic exenteration
- Patients undergoing ureterostomy
- Patients who underwent previous ureteral surgery (open, endoscopic or minimally invasive)
- Refusal to sign written informed consent
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.