to determine the feasibility of real-time detection and quantification of two NIRF optical contrast agents in the detection of sentinel and metastatic LNs in patients with cervical cancer during surgery with a novel NIRF imaging device to provide a…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the detection and location of metastatic (sentinel) lymph nodes in
patients with primary cervical cancer, by using a NIRF camera system.
Secondary outcome
-
Background summary
In surgical and gynaecological oncology, it can be difficult for the surgeon or
gynaecologist to determine tumour margins and lymph node (micro)metastases
intra-operatively. In order to remove all possible metastases, a complete
bilateral pelvic lymphadenectomy is performed in the case of cervical cancer.
Most of the time, not all lymph nodes are affected, leading to overtreatment
and more co-morbidity than in the case of a more selective excision of lymph
nodes.
In collaboration with the technical University of Munich, we have acquired an
intra-operative imaging system for fluorescence imaging. This could help the
gynaecologist in detecting tumour margins by providing real-time information on
tumour margins and lymph node metastases. In this research application, the
system will be tested with two fluorescent probes (one for lymph node
metastases, one for the sentinel node) in ten patients with cervical cancer.
The main outcome criterium is the possibility to detect the fluorescent signal
in lymph nodes, which will be examined histopathologically ex vivo.
Study objective
to determine the feasibility of real-time detection and quantification of two
NIRF optical contrast agents in the detection of sentinel and metastatic LNs in
patients with cervical cancer during surgery with a novel NIRF imaging device
to provide a platform technique for patient-tailored surgical interventions in
the future.
Study design
interventional phase 0 technical feasibility study / non-randomized, open
label, uncontrolled, single group assignment.
Study burden and risks
Patients with cervical cancer undergoing surgery (radical hysterectomy with
bilateral pelvic lymphadenectomy), will receive an intravenous injection with
folate-FITC four hours prior to surgery, followed by a peritumoural injection
with Indocyanine Green (ICG) and patent blue after administration of full
anaesthesia. During the operative procedure NIRF imaging for detection of the
SLN or metastatic LNs (i.e. ICG and patent blue and/or folate-FITC
accumulation) will take place.
The only risk is an anaphylactic reaction against ICG or folate-FITC. This has
seldomly been described. Therefore, patients will be monitored for 24 hours
after injection.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
women > 21 years of age with biopsy proven cervical cancer who are scheduled to undergo hysterectomy with pelvic lymphadenectomy
Exclusion criteria
Pregnant women, renal failure, cardiac or pulmonary diseases, allergy against iodine, previous anaphylactic or allergic reactions against insect bites or medication, hyperthyreoidism
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 | EUCTR2009-010560-42-NL |
| CCMO | NL26981.042.09 |