To test an intra-operative fluorescent camera system with a fluorescent optical agent in detection of the sentinel lymph node. This will be compared to the standard method with radiocolloid and patent blue.
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
the number and localisation of sentinel lymph node(s) detected with the camera
and ICG, compared to the detection with radiocolloid and patent blue
Secondary outcome
n/a
Background summary
Vulvar cancer is a disease that occurs in 2 per 100.000 women per year in the
Netherlands. Treatment exists of surgical removal of the tumour combined with
the sentinel node procedure with radiocolloid and patent blue. Affected lymph
nodes are excised. This requires an injection one day prio to surgery.
With the aid of an intra-operative fluorescent camera system and a fluorescent
optical agent, the sentinel node could possibly be detected intra-operatively.
If this is a safe and sensitive method, the injection one day prior to surgery
could be abandoned.
Study objective
To test an intra-operative fluorescent camera system with a fluorescent optical
agent in detection of the sentinel lymph node. This will be compared to the
standard method with radiocolloid and patent blue.
Study design
Phase 0 interventional / technical feasibility study, non-randomized,
uncontrolled, open label
Intervention
Injection of ICG together with patent blue (golden standard)
Study burden and risks
The burden on the patient consist of an injection with ICG during surgery,
under full anaesthesia. The risk of this injection is an allergic reaction.
Because the procedure takes place in the OR, such a reaction can be treated
directly and adequately. Also, there can be a green discolouration of the skin
on the site of injection. This will disappear within 2 weeks.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
female > 21 yrs of age with biopsy proven squamous cell carcinoma of the vulva who are eligible for a sentinel node procedure
Exclusion criteria
Pregnant women, significant renal (creatinine > 110 ug/l), 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 | EUCTR2009-010561-23-NL |
| CCMO | NL26982.042.09 |