Trial Outcomes & Findings for PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer (NCT NCT01737619)

NCT ID: NCT01737619

Last Updated: 2025-11-28

Results Overview

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2025-11-28

Participant Flow

The trial was active from April 2013 until May 2016 and all recruitments were done in a medical clinic setting.

Participant milestones

Measure	Sentinel Node Mapping Pre-op PET/CT scan followed by intraoperative sentinel lymph node mapping and biopsy then complete pelvic and para-aortic lymphadenectomy
Overall Study STARTED	101
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer

Baseline characteristics by cohort

Measure	Sentinel Node Mapping n=101 Participants Pre-op PET/CT scan followed by intraoperative sentinel lymph node mapping and biopsy then complete pelvic and para-aortic lymphadenectomy
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=30 Participants
Age, Categorical >=65 years	37 Participants n=30 Participants
Age, Continuous	62 years n=30 Participants
Sex: Female, Male Female	101 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	4 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	15 Participants n=30 Participants
Race (NIH/OMB) White	63 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=30 Participants
Region of Enrollment United States	101 participants n=30 Participants

PRIMARY outcome

Timeframe: 36 months

Outcome measures

Measure	Sentinel Node Mapping n=101 Participants Pre-op PET/CT scan followed by intraoperative sentinel lymph node mapping and biopsy then complete pelvic and para-aortic lymphadenectomy
False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers. , sensitivity of sentinel lymph node mapping	95 percentage
False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers. false negative rate	5 percentage
False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers. false negative predictive value	1.4 percentage

SECONDARY outcome

Timeframe: 36 months

Outcome measures

Measure	Sentinel Node Mapping n=101 Participants Pre-op PET/CT scan followed by intraoperative sentinel lymph node mapping and biopsy then complete pelvic and para-aortic lymphadenectomy
False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure false negative rate	4.3 percentage
False Negative Rate and False Negative Predictive Values of Lymphatic Spread of Endometrial Spread of Endometrial Lymph Nodes From a PET/CT Versus Lymphatic Mapping Procedure false negative predictive value	1.4 percentage

SECONDARY outcome

Timeframe: 36 months

Mortality percentage of patients following the lymph node mapping procedure and postoperative complications.

Outcome measures

Measure	Sentinel Node Mapping n=101 Participants Pre-op PET/CT scan followed by intraoperative sentinel lymph node mapping and biopsy then complete pelvic and para-aortic lymphadenectomy
Mortality Rate of Patients Undergoing Lymph Node Dissection Including Intra-operative and Postoperative Complications	0 percentage of participants

Adverse Events

Sentinel Node Mapping

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

Pamela Soliman, MD

M.D. Anderson Cancer Center

Phone: 713-745-2352

Email: psoliman@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place