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Printer Friendly Page Effectiveness of Lymph Node Mapping to Reduce the Risk of Swelling in the Legs in Patients with Stage I Endometrial Cancer

Effectiveness of Lymph Node Mapping to Reduce the Risk of Swelling in the Legs in Patients with Stage I Endometrial Cancer

Clinicaltrials.gov identifier:
NCT05646316

Treatment
People with stage I endometrial cancer who are having a hysterectomy

Study Contact Information:

For additional information, please contact Dr. Edward Tanner, PI at [email protected]


Effectiveness of Lymph Node Mapping to Reduce the Risk of Swelling in the Legs in Patients with Stage I Endometrial Cancer

About the Study

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs () in patients undergoing a hysterectomy for I endometrial cancer. Standard lymph node dissection removes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby . Sentinel lymph node mapping uses a special dye and camera to look for a specific lymph node most likely to contain cancer cells. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

What the Study Involves

Participants will be divided into one of two groups.

Group A: Participants will receive a special dye injected into the vein and undergo lymph node mapping and removal during a hysterectomy. around the uterus may be removed if the mapping and removal cannot be completed. Successful mapping requires no additional removal of .

Group B: Participants will receive a special dye injected into the vein and undergo lymph node mapping and removal during a hysterectomy. Additional around the uterus are removed per standard of care.

Participants in both groups also undergo imaging as needed and optional blood sample collection throughout the study.

After completion of study intervention, participants are followed every 3 months for one year and at 18 and 24 months.

Study Sites

District of Columbia

Washington University Medical Center
Contact: 202-741-2981
Principal Investigator: Nicole P. Chappell

Florida

Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact: 305-243-2647
Principal Investigator: Abdulrahman Sinno

Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact 305-243-2647
Principal Investigator: Abdulrahman Sinno

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: 305-243-2647
Principal Investigator: Abdulrahman Sinno

Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Contact: 305-243-2647
Principal Investigator: Abdulrahman Sinno

Illinois

Chicago
Northwestern University
Contact: 312-695-1301 or [email protected] 
Principal Investigator: Emily Hinchcliff

Warrenville
Northwestern Medicine Cancer Center Warrenville
Contact: 630-352-5360 [email protected]
Principal Investigator: Emily Hinchcliff

Indiana

Carmel
IU Health North Hospital
Contact: 317-278-5632 [email protected]
Principal Investigator: Lisa M. Landrum

Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center

Louisiana

Marrero
West Jefferson Medical Center
Contact: 504-210-3539 [email protected]
Principal Investigator: Tara Castellano

Metairie
East Jefferson General Hospital
Contact: 504-210-3539 [email protected]
Principal Investigator: Tara Castellano

New Orleans
Louisiana State University Health Science Center
Contact: 504-210-3539 [email protected]
Principal Investigator: Tara Castellano

University Medical Center New Orleans
Contact: 504-210-3539 [email protected]
Principal Investigator: Tara Castellano

Maryland

Baltimore
University of Maryland/Greenebaum Cancer Center
Contact: 800-888-8823
Principal Investigator: Gautam G. Rao

Michigan

Detroit
Wayne State University/Karmanos Cancer Institute
Contact: 313-576-9790 [email protected]
Principal Investigator: Robert T. Morris

Farmington Hills
Weisberg Cancer Treatment Center
Contact: 313-576-9790 [email protected]
Principal Investigator: Robert T. Morris

Flint
McLaren Cancer Institute-Flint
Contact: 313-576-9790 [email protected]
Principal Investigator: Robert T. Morris

Minnesota

Edina
Fairview Southdale Hospital
Contact: 952-993-1517 [email protected]
Principal Investigator: Britt K. Erickson

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: 952-993-1517 [email protected]
Principal Investigator: Britt K. Erickson

Maplewood
Saint John's Hospital - Healtheast
Contact: 952-993-1517 [email protected]
Principal Investigator: Britt K. Erickson

Princeton
Fairview Northland Medical Center
Contact: 952-993-1517 [email protected]
Principal Investigator: Britt K. Erickson

Saint Paul
Regions Hospital
Contact: 952-993-1517 [email protected]
Principal Investigator: Britt K. Erickson

Wyoming
Fairview Lakes Medical Center
Contact: 952-993-1517 [email protected]
Principal Investigator: Britt K. Erickson

Missouri

Springfield
Mercy Hospital Springfield
Contact: 417-269-4520
Principal Investigator: Jay W. Carlson

Nebraska

Omaha
University of Nebraska Medical Center
Contact: 402-559-6941 [email protected]
Principal Investigator: Kerry J. Rodabaugh

Nevada

Las Vegas
Women's Cancer Center of Nevada
Contact: 702-693-6870 [email protected]
Principal Investigator: Nicola M. Spirtos

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Contact: 405-271-8777 [email protected]
Principal Investigator: Joan L. Walker

Pennsylvania

Bryn Mawr
Bryn Mawr Hospital
Contact: 484-476-2649 [email protected]
Principal Investigator: Deric C. Savior

Paoli
Paoli Memorial Hospital
Contact: 484-476-2649 [email protected]
Principal Investigator: Deric C. Savior

Wynnewood
Lankenau Medical Center
Contact: 484-476-2649 [email protected]
Principal Investigator: Deric C. Savior

Rhode Island

Providence
Women and Infants Hospital
Contact: 401-274-1122
Principal Investigator: Matthew T. Oliver

Texas

Dallas
Parkland Memorial Hospital
Contact: 214-590-5582 [email protected]
Principal Investigator: Jayanthi S. Lea

UT Southwestern/Simmons Cancer Center-Dallas
Contact: 214-590-5582 [email protected]
Principal Investigator: Jayanthi S. Lea

Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: 972-669-7044 [email protected]
Principal Investigator: Jayanthi S. Lea

Virginia

Charlottesville
University of Virginia Cancer Center
Contact: 434-243-6303 [email protected]
Principal Investigator: Kari L. Ring

This Study is Open To:

People, aged 18 years and older, who meet the following criteria:

  • Diagnosed with I endometrial cancer and plan to have a laparoscopic or robotic hysterectomy and lymphatic assessment as part of their primary management.

  • Speaks English or Spanish.

This Study is Not Open To:

People who are under the age of 18 and who:

  • Are assigned male at birth.

  • Had chemotherapy or for endometrial cancer except progestin-containing therapies and levonorgestrel-containing intrauterine device (IUD).

  • Had radiation to the pelvis, groin, or lower extremities or surgery to in the pelvis or groin area.

  • Will undergo another surgery at the same time as endometrial surgery.

  • Have another disease or medical condition such as lower extremity or chronic lower extremity swelling.

  • Have lower extremity or pelvic deep venous thromboembolism (occurs when a blood clot breaks off and travels through the bloodstream, blocking a blood vessel) or lower extremity cellulitis (a bacterial skin infection) within 90 days of registration.