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

• Status: Completed
• Trial end date: 2016-07-16
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: NRG Oncology
• Treatments: Fluorodeoxyglucose F18

Criteria

Inclusion Criteria:

• 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

• No history of anaphylactic or life-threatening allergic reactions to any contrast media

• No other invasive malignancies within the past 5 years with the exception of nonmelanoma skin cancer

• No contraindication to MRI (e.g., severe claustrophobia, pacemaker, aneurysm clips, defibrillators, or other institutional contraindication to MRI)

• No history of allergic reactions attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations)

• No immunodeficiencies that would predispose patient to specific or nonspecific mediator release

• No history of cirrhosis

• No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level > 200 mg/dL)

• No prior pelvic or abdominal lymphadenectomy

• No prior pelvic radiotherapy

• No prior anticancer therapy that would contraindicate study participation

• No ferumoxides within the past 2 weeks

• No investigational agents within the past 30 days

• No other concurrent investigational agents