No registrations found.
ID
Source
Brief title
Health condition
ovarian cancer
eierstokkanker
ovariumkanker
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intra-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 outcome
Presence of fluorescent residual disease after intended radical resection by visual observation alone.
Background summary
This 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.
Study objective
Improved detection of tumor.
Study design
Debulking surgery.
Intervention
Administration of folate-FITC prior to surgery. During surgery, a near-infrared fluorescence intra-operative camera system will be used to detect residual tumor tissue.
Department of Surgery / BioOptical Imaging Center Groningen <br>
G.M. Dam, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3612283
g.m.van.dam@chir.umcg.nl
Department of Surgery / BioOptical Imaging Center Groningen <br>
G.M. Dam, van
Hanzeplein 1
Groningen 9700 RB
The Netherlands
+31 (0)50 3612283
g.m.van.dam@chir.umcg.nl
Inclusion criteria
1. Female > 21 years old;
2. Ovarian cancer for which debulking surgery is scheduled.
Exclusion criteria
1. Renal, cardiac or pulmonary failure (ASA III-IV);
2. Present or previous hyperthyreoidism;
3. Iodine allergy or previous anaphylactic reactions;
4. Pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1867 |
| NTR-old | NTR1980 |
| Other | UMCG/CCMO : BICG07UMCG-NIRF/NL26980.042.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |