Study on Indocyanine Green for Evaluating Blood Flow in Surgery for Women with Recurrent or Persistent Gynecological Cancer

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What is this study about?

This clinical trial is focused on patients with gynecological cancers who are undergoing a major surgical procedure called pelvic exenteration. This surgery is often performed when the cancer has returned or is persistent. The study is investigating the use of a special dye called Indocyanine Green, which is given as an injection. This dye helps doctors see how well blood is flowing to certain areas during surgery. The main goal is to assess the blood supply to a part of the body called the ileal conduit, which is used to help with urine drainage after surgery. The study also aims to help surgeons decide how much of the ureter, a tube that carries urine from the kidney to the bladder, needs to be removed during the operation.

Participants in the study will receive the Indocyanine Green injection during their surgery. The study will monitor the rate of complications that can occur after surgery, such as blockages where the ureter connects to the ileal conduit, and any leaks from the ureter. Researchers will also look at kidney function over time and track the overall survival and progression-free survival of participants for up to 12 months. The study will help determine if using this dye can improve surgical outcomes and patient recovery.

The trial is expected to run until 2026, and it began recruiting participants in March 2023. This research is important for improving surgical techniques and outcomes for patients with recurrent or persistent gynecological cancers undergoing complex surgeries. By using Indocyanine Green, doctors hope to make more informed decisions during surgery, potentially leading to better recovery and fewer complications for patients.

1 joining the study

Participation begins after signing a written informed consent form. Eligibility includes being between 18 and 75 years old, having a confirmed recurrence or persistence of cervical, vulvar, vaginal, or endometrial cancer suitable for pelvic exenteration, and an estimated life expectancy of at least four weeks.

2 pre-surgery assessment

Before surgery, an assessment is conducted to evaluate the vascularity of the ileal conduit using indocyanine green (ICG). This involves an intravenous administration of ICG to help visualize blood flow and guide surgical decisions.

3 surgical procedure

During the pelvic exenteration surgery, ICG is used to assess the vascularity of the ileal conduit anastomosis and to regulate ureteral resection margins. This helps ensure that the blood supply to the surgical area is adequate.

4 post-surgery monitoring

After surgery, monitoring focuses on the rate of benign uretero-enteric stricture and post-operative complications. Complications are categorized as early (within 30 days) and late (from day 31 to day 180).

5 follow-up assessments

Follow-up includes evaluating renal function over time, measured at baseline, 1, 3, and 6 months, based on fluorescence levels. Additionally, overall survival and progression-free survival are assessed at 12 months.

Who Can Join the Study?

  • Must be a woman aged 18 years or older and younger than 75 years.
  • Have a recurrence, progression, or persistence of cervical, vulvar, vaginal, or endometrial cancer that is suitable for a surgical procedure called pelvic exenteration. This must be confirmed by examining tissue samples under a microscope.
  • Have an estimated life expectancy of at least 4 weeks.
  • Must have signed a written informed consent, which means you agree to participate in the study after being informed about it.

Who Cannot Join the Study?

  • Patients who are not undergoing surgery for gynecological cancers.
  • Patients who are not having a procedure called pelvic exenteration, which is a major surgery to remove organs from the pelvic area.
  • Patients who are not having a procedure called ileal conduit, which is a type of surgery to create a new way for urine to leave the body.
  • Patients who are not undergoing a specific type of surgery involving the ureters, which are tubes that carry urine from the kidneys to the bladder.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are under the age of 18 or over the age of 65, as the study is for adults between these ages.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
01.03.2023

Trial locations

Investigated drugs:

Indocyanine Green is a dye used in this study to help doctors see how well blood is flowing in certain areas of the body. It is injected into the bloodstream and helps highlight blood vessels during surgery. This can assist surgeons in making decisions about where to cut or remove tissue, ensuring that the remaining tissue has a good blood supply.

Gynecological Cancers – These are cancers that occur in the female reproductive system, including the cervix, ovaries, uterus, vagina, and vulva. They often begin with abnormal cell growth in these areas, which can form tumors. As the disease progresses, it may spread to nearby tissues and organs. Symptoms can vary depending on the type and location of the cancer but may include abnormal bleeding, pelvic pain, and changes in menstrual cycles. Early stages might not present noticeable symptoms, making regular screenings important. The progression can lead to more severe symptoms and complications if not addressed.

Trial ID:
2024-518783-13-00
Protocol code:
GREEN-EX
Trial Phase:
Therapeutic exploratory (Phase II)

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