Trial Outcomes & Findings for Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer (NCT NCT00070317)
NCT ID: NCT00070317
Last Updated: 2017-11-06
Results Overview
Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
At the time of surgery
Results posted on
2017-11-06
Participant Flow
This trial was opened to patient entry on June 21, 2004 and was closed to entry July 21, 2008.
Participant milestones
| Measure |
Radionuclide and Isosulfan Blue Injection
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
89
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Radionuclide and Isosulfan Blue Injection
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid
|
|---|---|
|
Overall Study
Inevaluable (Never Treated)
|
1
|
|
Overall Study
Ineligible Wrong Cell type/primary/stage
|
3
|
|
Overall Study
Ineligible required test not done
|
1
|
|
Overall Study
Ineligible-Improper prior treatment
|
2
|
|
Overall Study
Ineligible-Inadequate pathology
|
6
|
Baseline Characteristics
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic
n=89 Participants
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid
|
|---|---|
|
Age, Customized
20-29 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
23 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
31 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
17 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
9 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of surgeryPopulation: Eligible and evaluable patients with lymph node metastasis and identified sentinel node
Sensitivity is defined as the proportion of patients who test as positive sentinel node among the patients who have lymph node metastases.
Outcome measures
| Measure |
Diagnostic
n=21 Participants
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid
|
|---|---|
|
Sensitivity
|
85.7 Percentage of participants
Interval 67.0 to 96.0
|
PRIMARY outcome
Timeframe: At the time of SurgeryPopulation: Eligible and evaluable patients who tested as negative sentinel node and have lymph node sampling
The proportion of patients with FNPV among patients who tests as negative sentinel node, where FNPV is defined as a person who tests as negative sentinel node but who actually has lymph node metastases
Outcome measures
| Measure |
Diagnostic
n=51 Participants
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid
|
|---|---|
|
False Negative Predictive Value (FNPV)
|
5.9 Percentage of participants
Interval 2.0 to 15.0
|
Adverse Events
Diagnostic
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diagnostic
n=89 participants at risk
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
Isosulfan Blue: Undergo lymphangiography using isosulfan blue or methylene blue Lymph Node Mapping: Undergo lymphatic mapping Lymphangiography: Undergo lymphangiography using isosulfan blue or methylene blue Methylene Blue: Undergo lymphangiography using isosulfan blue or methylene blue Radionuclide Imaging: Undergo radionuclide imaging with technetium Tc 99m sulfur colloid Sentinel Lymph Node Biopsy: Undergo complete pelvic and low para-aortic lymphadenectomy Technetium Tc-99m Sulfur Colloid: Undergo radionuclid
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
22.5%
20/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Blood and lymphatic system disorders
Other Blood/Bone Marrow
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Blood and lymphatic system disorders
Neutrophils
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Cardiac disorders
Cardiac
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
General disorders
Constitutional Symptoms
|
9.0%
8/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Gastrointestinal disorders
Other Gastrointestinal
|
3.4%
3/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Infections and infestations
Infection
|
4.5%
4/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Blood and lymphatic system disorders
Lymphocele
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Blood and lymphatic system disorders
Other Lymphatics
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory
|
2.2%
2/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
General disorders
Pain
|
6.7%
6/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Renal and urinary disorders
Renal/Genitourinary
|
3.4%
3/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Surgical and medical procedures
Intra-Op Injury: Ureter
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
1.1%
1/89 • All treatment-related adverse events which occurred within 30 days of study surgical procedure are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60