To test a near-infrared fluorescence camerasystem in order to detect folate-FITC in tumour tissue in women with ovarian cancer who undergo cytoreductive surgery.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
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 (proven bij biopsy)
Background summary
Ovarian cancer is a disease that is usually detected in a late stage, when the
disease has already spread and/or has formed metastases. This leads to a bad
prognosis. Treatment consists of cytoreductive surgery, in which as much tumour
tissue as possible is removed. The extent of cytoreduction; i.e. the amount of
tumour tissue that is removed and the size of residual disease afterwards; has
great influence on the prognosis. By removing more tumour tissue during
cytoreductive surgery, the prognosis can be improved.
Tactile and visual observation ("naked eye") are currently the only ways in
which the surgeon / gynecologic oncologist can assess the presence of tumour
tissue. In this study, we will test a near-infrared fluorescence (NIRF) camera
system in order to detect tumour tissue intra-operatively. The fluorescent
signal is created by injecting a fluorescent tracer prior to surgery.
Subesequently, the operative procedure is carried out as usual. The only
difference in this are the moments in which an optical image is acquired by the
intra-operative camera. WIth the aid of these images, the surgeon / gynecologic
oncologist could detect more tumour tissue. This will possibly result - in the
future - in a more complete cytoreduction with less residual disease. This
influences prognosis in a positive manner.
Study objective
To test a near-infrared fluorescence camerasystem in order to detect
folate-FITC in tumour tissue in women with ovarian cancer who undergo
cytoreductive surgery.
Study design
Interventional phase 0 technical feasibility study: non-randomized, open label,
uncontrolled with single group assignment.
Study burden and risks
Before the surgical procedure, patients undergo one extra test that is normally
not a part of the pre-operative diagnostic testing:
- Pregnancy test; in case of a postive pregnancy test, patient will be excluded
from the study.
Four hours prior to surgery, patients will receive an intravenous injection
with folate-FITC. The biggest risk of this is an allergic or anaphylactic
reaction.
The use of the intera-operative camera does not cause any risk in itself, but
by using the camera, the total operative time can be extended with ~15 minutes.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
female > 21 yrs of age; operable ovarian carcinoma
Exclusion criteria
Pregnant women, significant renal, cardiac, or pulmonary disease (ASA III-IV), History of iodine allergy or anaphylactic reactions to insect bites or medication, presence or history of hyperthyroidism
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2009-010559-29-NL |
| CCMO | NL26980.042.09 |