Trial Outcomes & Findings for Sentinel Node Detection in Clinical Early Stage Ovarian Cancer (NCT NCT01734746)
NCT ID: NCT01734746
Last Updated: 2018-11-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
During surgery.
Results posted on
2018-11-05
Participant Flow
Participant milestones
| Measure |
Sentinel Node Procedure
Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.
blue dye and radioactive tracer
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sentinel Node Detection in Clinical Early Stage Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Sentinel Node Procedure
n=22 Participants
Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.
blue dye and radioactive tracer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
|
Age, Continuous
|
58.6 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
21 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During surgery.Population: see Kleppe et al., J Nucl Med 2014; 55:1799-1804
Outcome measures
| Measure |
Sentinel Node Procedure
n=21 Participants
Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.
|
|---|---|
|
Number of Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments.
|
21 participants
|
SECONDARY outcome
Timeframe: During surgery.The number of patients with only paraaortic/paracaval, only pelvic, and both paraaortic/paracaval and pelvic sentinel node locations.patients.
Outcome measures
| Measure |
Sentinel Node Procedure
n=21 Participants
Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.
|
|---|---|
|
Anatomical Location(s) of the Sentinel Nodes.
SN only paraaortic
|
14 participants
|
|
Anatomical Location(s) of the Sentinel Nodes.
SN only pelvic
|
2 participants
|
|
Anatomical Location(s) of the Sentinel Nodes.
SN both paraortic and pelvic
|
5 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During surgery.Outcome measures
| Measure |
Sentinel Node Procedure
n=21 Participants
Injection of both blue dye and the radioactive isotope (technetium-99-m-labeled albumin nanocolloid) in the ligamentum ovarii proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), close to the ovary and just below the peritoneum.
|
|---|---|
|
Number of Patients With False Negative Sentinel Nodes.
|
0 participants
|
Adverse Events
Sentinel Node Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place