1) To determine whether or not a SN procedure in patients with OC is feasible through injection of the tracers in the ovarian ligaments, when the ovarian tumour has already been resected.2) To determine if blue colorization of the sentinel nodes is…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients in whom it is feasible to identify sentinel nodes in
case the malignant ovarian mass has already been resected.
Secondary outcome
- To determine if blue colorization of the sentinel nodes is related to the
time-interval between injection and retroperitoneal exploration?
- To determine if the technique becomes more accurate by using a mobile
gamma-camera and / or multimodality radioactive and fluorescence guidance
during the surgical procedure.
Background summary
As most cancers, ovarian cancer also spreads to regional lymph nodes. The
concept of sentinel lymph node surgery is to see whether the cancer has spread
to the very first lymph node or sentinel node (SN). If the SN does not contain
cancer, then there is a high likelihood that the cancer has not spread to other
lymph nodes. This means that, at least theoretically, a radical lymphadenectomy
could be omitted and thus the associated morbidity. The SN technique has been
proven to be effective in other cancers such as breast cancer and malignant
melanoma. In the gynaecological field it has been shown to be effective in
vulvar cancer. Recently we have shown that the SN procedure performed through
the injection of tracers into the ovarian ligaments is feasible and promising
in patients with clinical early stage ovarian cancer (OC). Injection of
radioactive tracers resulted in the identification of SNs in all 21 patients.
Before a multicentre randomized controlled trial can be initiated, still some
questions have to be answered.
Study objective
1) To determine whether or not a SN procedure in patients with OC is feasible
through injection of the tracers in the ovarian ligaments, when the ovarian
tumour has already been resected.
2) To determine if blue colorization of the sentinel nodes is related to the
time-interval between injection and retroperitoneal exploration?
3) To determine if the technique becomes more accurate by using a mobile
gamma-camera and / or multimodality radioactive and fluorescence guidance
during the surgical procedure.
Study design
phase I feasibility study.
Intervention
During surgery tracers are injected in the ovarian ligaments to identify
sentinel node(s).
Study burden and risks
In case the tracer is injected with the adnexal mass still in situ, the surgery
is prolonged at maximum with 20-25 minutes due to the required incubation time
after injection of the blue dye and radioactive isotope. A scintigram will be
performed 24 hours after the surgery to determine whether residual radioactive
lymph nodes can be detected. The scintigram will only be performed if the
patient is capable to be transported to the nuclear department. No extra blood
samples will be taken, no extra visits, physical examinations or other tests
are necessary. There is no risk of tumour dissemination by injecting the
tracers in the ovarian ligaments. There is a 0,07 to 2,7% risk of an allergic
reaction to the blue dye. The dose of radioactive isotope given does not give
adverse side effects, either to the patients or the personnel present in the
operating theatre.
P Debeyelaan 25
Maastricht 6229HX
NL
P Debeyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
- Patients with a high suspicion of a malignant ovarian tumour planned for exploratory laparotomy with frozen section, staging procedure in case of malignancy.
- Patients in whom the ovarian malignant tumour has already been resected and a second surgical procedure is planned to complete the staging procedure including lymph nodes.
Exclusion criteria
- Age <18
- Age > 85 years.
- Mentally incompetent to give informed consent.
- Previous vascular surgery of the aorta, caval vein, and/or iliac vessels.
- Previous lymphadenectomy of lymph node sampling in the iliac or para-aortal region.
- History of a malignant lymphoma.
- History of a malignant tumour in the abdominal cavity.
- Previous allergic reaction to blue dye.
- An allergy for human albumin.
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 |
|---|---|
| ClinicalTrials.gov | NCT02540551 |
| CCMO | NL53246.068.15 |