Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer

Completed · Phase 1/Phase 2

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Stage I Endometrial Carcinoma, Stage IB Cervical Cancer, Stage II Endometrial Carcinoma, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage IVA Cervical Cancer

In brief

This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.

Key facts

Study ID

NCT00416455

Run by

National Cancer Institute (NCI)

People needed

384

Starts

2007-09-01

Expected to finish

2016-07-16

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed diagnosis of 1 of the following:
• Invasive carcinoma of the cervix meeting all of the following criteria:
• Previously untreated, primary disease
• Locoregionally advanced (stage IB2, IIA [>= 4 cm], or IIB-IVA) disease
• Any cell type allowed
• High-risk endometrial carcinoma meeting 1 of the following criteria:
• Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma diagnosed from an endometrial biopsy or dilation and curettage or
• Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage
• Under consideration for chemoradiotherapy (patients with cervical cancer)
• Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
• Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling
• No surgery for patients with advanced lymphadenopathy
• No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment
• No known metastases to the lungs or scalene lymph nodes
• No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis
• Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol
• Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG)
• GOG performance status 0-2
• Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be > 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol
• Ferritin levels =< 600 ng/mL OR saturation of transferrin level =< 50%
• Patients with high levels of ferritin or transferrin are eligible if documented hematology rules out iron overload
• Not pregnant or nursing
• Negative pregnancy test
• No patients weighing greater than that allowable by the PET/CT scanner
• No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy

Where it is running

• Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• University of California at Los Angeles Health System — Los Angeles, California, United States
• Olive View-University of California Los Angeles Medical Center — Sylmar, California, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Georgia Regents University Medical Center — Augusta, Georgia, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• UMDNJ - New Jersey Medical School — Newark, New Jersey, United States
• Island Gynecologic Oncology — Brightwaters, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Providence Cancer Center -The Plaza — Portland, Oregon, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• CHUQ - Pavilion Hotel-Dieu de Quebec — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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