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Sentinel Node in Ovarian Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Sentinel Node

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Trial Information

Sentinel Node in Ovarian Cancer


According to the International Federation of Gynecology and Obstetrics (FIGO), EOC with
lymph node metastases is classified as FIGO stage IIIC disease, even in the absence of
peritoneal metastases. In contrast to patients with FIGO stage I ovarian cancer after a
comprehensive staging procedure, patients with a FIGO stage III ovarian cancer obtain
adjuvant chemotherapy. Therefore, the recognition of lymph node metastases is of utmost
importance. In general, the incidence of lymph node metastases in clinical early stage EOC
is approximately 14%, and depends on subtype histology (i.e. serous 23%, mucinous 3%) and
differentiation grade (4% and 20% in grade 1 and 3 tumors respectively).

Surgical staging of EOC and the extent of lymph node dissection differs greatly from centre
to centre. In case of a clinical early stage ovarian cancer, the Dutch guideline recommends
a staging laparotomy with adequate lymph node sampling, with an absolute minimum of ten
lymph nodes removed. In the same guideline, a footnote is made stating that a larger number
of removed lymph nodes will increase the chance of finding metastases. These lymph nodes
also need to be sampled from different anatomical regions, of which the most important are
the para-aortic and paracaval region between the renal vein and inferior mesenteric artery,
the common, internal and external iliac vessels and the obturator fossa.

A systematic lymphadenectomy can be seen as the golden standard. However, such a radical
procedure gives more late morbidity than lymph node sampling. These include the formation of
lymphocyst (up to 13.5%), nerve and vessel injury (up to 4%), and increased blood loss and
operating time [26, 27]. Studies done for sentinel node in ovarian cancer are very limited
and performed in women with uterine cancer by injecting the tracers in the ovary. In case of
ovarian cancer such a procedure gives a possible risk of tumour dissemination. In this
feasibility study the tracers are injected in the ligaments of the ovary, not in the cortex
itself.

Patients with (suspicion of) ovarian cancer as well as patients with a high-grade uterine
carcinoma will be included. The latter group of patients can also be included because these
patients undergo the same surgical procedure; TAH with BSO and a pelvic and para-aortic
lymphadenectomy or lymph node sampling.

Both blue dye and the radioactive isotope will be injected in the ligamentum ovarii proprium
(median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and
just below the peritoneum.

In case of an ovarian tumor: after 15 minutes time-interval the ovarian mass will be removed
and presented to the pathologist for a frozen section. If the result is benign, no further
actions will be performed in these patients. If the result is malignant, the sentinel
node(s) will be identified either by the radioactive tracer and / or visually (blue dye)
after opening the retroperitoneal space. After removal of the sentinel node(s) a complete
standard staging procedure will be performed including a comprehensive sampling of other
lymph nodes at the different locations.

In case of endometrial cancer: after 15 minutes time-interval the surgical staging procedure
starts with a TAH and BSO. After approximately 45 minutes the sentinel node(s) will be
identified either by the radioactive tracer and / or visually (blue dye) after opening the
retroperitoneal space. This 45 minutes time-interval is chosen to mimic the time interval
when a frozen section is performed in case of an ovarian tumor. After removal of the
sentinel node(s) a complete standard staging procedure will be performed including a
comprehensive at random sampling of other lymph nodes at the different locations.


Inclusion Criteria:



- Patients with a high suspicion of a malignant ovarian tumour planned for exploratory
laparotomy.

- Patients with high-risk endometrial cancer in whom a staging laparotomy is planned.

- Age between 18 and 85 years.

Exclusion Criteria:

- Previous surgery of both ovaries.

- 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.

- Pregnant or lactating patients.

- An allergy for human albumin.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of patients (%) in which sentinel node(s) are detected after injection of blue dye and tracer in the ovarian ligaments.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Roy Kruitwagen, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Maastricht UMC

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

NL40323.068.12

NCT ID:

NCT01734746

Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Ovarian Cancer
  • Sentinel Node
  • ovarian cancer
  • sentinel node
  • Ovarian Neoplasms

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