Primary Objective: - Determine whether or not a sentinel node procedure in patients with ovarian cancer is feasible.Secondary Objective(s): - The anatomical location(s) of the sentinel node(s).- Incidence of false negative nodes.
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 sentinel node(s) will be identified.
Secondary outcome
- Location of the sentinel node(s)
- Incidence of false negative nodes.
Background summary
As most cancers, ovarian cancer also spreads to regional lymph nodes. The
sentinel lymph node is hypothetical the first lymph node or group of nodes
draining a cancer. If the sentinel node(s) does not contain cancer, there is a
high likelihood that the cancer has not spread to other lymph nodes. This means
that, at least theoretically, a radical lymphadenectomy or extensive lymph node
sampling could be omitted and thus the associated morbidity. The sentinel node
technique was proven to be effective in other cancers such as breast cancer and
malignant melanoma, and in the gynaecological field in vulvar cancer. Currently
sentinel node studies are done for cervix en uterine cancer.
Study objective
Primary Objective:
- Determine whether or not a sentinel node procedure in patients with ovarian
cancer is feasible.
Secondary Objective(s):
- The anatomical location(s) of the sentinel node(s).
- Incidence of false negative nodes.
Study design
Phase I: feasibility study to detect sentinel nodes: mapping the lymphatic
drainage of the ovaries.
Study burden and risks
The surgery is prolonged with 20-25 minutes due to the required incubation time
after injection of the blue dye and radioactive isotope. A scintigram will be
performed the day 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 a 0.9% risk of an allergic reaction to the blue dye of
which 0.07% severe (anaphylactic shock). 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. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
The following patients will be included:
Cohort 1: patients with a high suspicion of an ovarian malignancy in whom a median laparotomy and a frozen section analysis is planned.
Cohort 2: patients with endometrial cancer in whom a staging laparotomy is planned.
Exclusion criteria
- Previous surgery of the 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
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 |
|---|---|
| CCMO | NL40323.068.12 |