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Detection of residual tumor tissue during surgery in ovarian cancer.


- candidate number6379
- NTR NumberNTR1980
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-aug-2009
- Secondary IDsBICG07UMCG-NIRF/NL26980.042.09 UMCG/CCMO
- Public TitleDetection of residual tumor tissue during surgery in ovarian cancer.
- Scientific TitleDetection of residual disease using Folate-FITC enhanced optical imaging in ovarian carcinoma.
- ACRONYMN/A
- hypothesisImproved detection of tumor.
- Healt Condition(s) or Problem(s) studiedOvarian cancer
- Inclusion criteria1. Female > 21 years old;
2. Ovarian cancer for which debulking surgery is scheduled.
- Exclusion criteria1. Renal, cardiac or pulmonary failure (ASA III-IV);
2. Present or previous hyperthyreoidism;
3. Iodine allergy or previous anaphylactic reactions;
4. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate
- Target number of participants10
- InterventionsAdministration of folate-FITC prior to surgery. During surgery, a near-infrared fluorescence intra-operative camera system will be used to detect residual tumor tissue.
- Primary outcomeIntra-operative detection of ovarian cancer by a folate-FITC enhanced optical imaging device, in which visual inspection in combination with routine histology is considered the golden standard for the presence of tumour tissue.
- Secondary outcomePresence of fluorescent residual disease after intended radical resection by visual observation alone.
- TimepointsDebulking surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.M. Dam, van
- CONTACT for SCIENTIFIC QUERIESDr. G.M. Dam, van
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThis project consists of the realization followed by the clinical validation of a procedure dedicated to residual disease localization in the case of ovarian cancer. An intra-operative near-infrared fluorescence (NIRF) imaging camera and the use of a NIRF optical contrast agent will be evaluated for its feasibility to detect residual disease in patients with ovarian cancer. In order to improve the prognosis of ovarian cancer, residual disease is one of the few factors that can be influenced by more optimal cytoreductive surgery. The end-goal of this intra-operative imaging procedure is to significantly improve the detection and efficiency of the technique in order to reduce the amount of residual tumour tissue. Gynecologic oncologists, surgeons and fundamental physics applied to medical imaging researchers are involved in this project.
- Main changes (audit trail)
- RECORD31-aug-2009 - 12-okt-2009


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