• Diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning [ Designated as safety issue: No ]
• Diagnostic sensitivity and specificity of preoperative ferumoxtran-10 MRI scanning [ Designated as safety issue: No ]

• Diagnostic accuracy of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning
• Diagnostic accuracy of preoperative ferumoxtran-10 MRI scanning

• Comparison of the diagnostic sensitivity and specificity of PET/CT scan vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes [ Designated as safety issue: No ]
• Comparison of the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis [ Designated as safety issue: No ]
• Percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning [ Designated as safety issue: No ]
• Accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer [ Designated as safety issue: No ]
• Complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer [ Designated as safety issue: No ]
• Cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer [ Designated as safety issue: No ]
• Adverse events, including those associated with ferumoxtran-10 [ Designated as safety issue: Yes ]

• Complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy
• Complications from surgery and imaging
• Sensitivity and specificity

RATIONALE: 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.

PURPOSE: 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.

OBJECTIVES:

Primary

• Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in patients with locoregionally advanced cervical carcinoma.
• Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial cancer.

Secondary

• Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
• Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these patients.
• Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in these patients.
• Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis, in these patients.
• Determine the percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning.
• Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer.
• Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer.
• Determine the cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer.
• Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
• Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty patients.

OUTLINE: This is a multicenter study.

Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2.

Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.

After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 380 patients will be accrued for this study.

• Cervical Cancer
• Endometrial Cancer

• Drug: ferumoxtran-10
• Procedure: diagnostic lymphadenectomy
• Procedure: lymph node biopsy
• Procedure: lymphadenectomy
• Procedure: magnetic resonance imaging
• Procedure: positron emission tomography/computed tomography
• Radiation: fludeoxyglucose F 18

DISEASE CHARACTERISTICS:

• 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
    • 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)

• 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

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• Creatinine normal OR creatinine clearance > 60 mL/min

• 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
• Weight ≤ 300 lbs
• 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)

PRIOR CONCURRENT THERAPY:

• 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

• National Cancer Institute (NCI)
• Gynecologic Oncology Group