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Source: isrctn - Le promoteur: Leiden University Medical Center (Netherlands)
Leiden University Medical Center (Netherlands) MAJ Il y a 4 ans

Intraoperative detection of ovarian cancer metastases using near-infrared fluorescence imaging and indocyanine green Background and study aims Ovarian cancer is one of the most common cancers among women. Unfortunately, because early symptoms can be vague and somewhat similar to other conditions, it is often not diagnosed until it has reached an advanced stage and spread (metastasized) to other areas of the body. Surgery is useful in two ways; to remove tumors and to discover how far the cancer has spread (known as tumor staging). It is sometimes difficult to see all the tumors until surgery has begun and finding them all even during surgery can be a challenge, particularly when trying to find smaller ones. However, a new method, near-infrared fluorescent (NIRF) imaging has been developed that can see ovarian tumor tissue during surgery. In early studies it has been shown that ovarian cancer can be identified using NIRF imaging and a special dye called near-infrared fluorescent dye indocyanine green. This is because the dye tends to accumulate in tumors much more readily than they do in normal tissues (called the enhanced permeability and retention - or EPR - effect). We want to see how many tumors are seen using the new technique. Who can participate? Adult women aged at least 18 years either diagnosed with, or suspected to have, ovarian cancer and due for tumor staging or cytoreductive surgery (surgery to remove the tumor(s)) . What does the study involve? Ovarian cancer patients have indocyanine green given to them intravenously during surgery and NIRF performed to make the tumors easier to see. The number of tumors are then counted and a health professional (pathologist) then looks at the tumors that are removed to see how advanced the disease has become. What are the possible benefits and risks of participating? Possible benefits include finding more tumors that would otherwise be the case during surgery. A possible risk is an allergic reaction to indocyanine green. However, this is very rare (< 1 out of 20.000) and can be managed by the anaesthesiologist. Where is the study run from? Leiden University Medical Center (Netherlands) When is the study starting and how long is it expected to run for? October 2012 to October 2015 Who is funding the study? Leiden University Medical Center (Netherlands) Who is the main contact? Dr Alexander Vahrmeijer [email protected] Dr. Katja Gaarenstroom [email protected]

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