• 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 ]
  

• Complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy [ Designated as safety issue: No ]
  
• Complications from surgery and imaging [ Designated as safety issue: No ]
  
• Sensitivity and specificity [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT 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 ferumoxtran-10 MRI scanning in identifying metastases to abdominal lymph nodes in these patients.

Secondary

• Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in these patients.
• Compare the diagnostic sensitivity and specificity of preoperative ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes vs combined pelvic and abdominal lymph nodes in these patients.
• 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 who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning.
• Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy, including delay in the initiation of radiotherapy or interruption of radiotherapy in these patients.
• Collect data on the adverse effects of the ferumoxtran-10 agent in these patients.

OUTLINE: This is a multicenter study.

Patients undergo fludeoxyglucose F 18-positron emission tomography (FDG-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 or laparoscopic pelvic and abdominal lymph node biopsy on day 16. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. All patients undergo chemoradiotherapy within 4 weeks of lymph node sampling.

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 325 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed invasive carcinoma of the cervix meeting all of the following criteria:

  • Primary, previously untreated disease
  • Locoregionally advanced (stage IB2, IIA [≥ 4 cm], or IIB-IVA) disease
  • Any cell type
• Under consideration for chemoradiation therapy
• No recurrent invasive carcinoma of the 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
• Able to undergo extraperitoneal or laparoscopic lymph node sampling

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Lactic dehydrogenase ≤ 2.5 times ULN
• Albumin normal
• PTT normal
• AST and ALT ≤ 2.5 times ULN
• Creatinine normal OR creatinine clearance > 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Patient weight ≤ 300 lbs
• No septicemia or severe infection
• No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy

• No uncontrolled intercurrent illness, including but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would limit compliance with study requirements
• No history of anaphylactic or life-threatening allergic reactions to any contrast media
• No other invasive malignancies, with the exception of nonmelanoma skin cancer, or any evidence of other cancer within the past 5 years
• 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

• Ferritin levels ≤ 600 ng/mL OR saturation of transferrin level ≤ 50%

  • Patients with high levels of ferritin or transferrin allowed if documented hematology rules out iron overload
• No history of cirrhosis
• No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level > 200 mg/dL)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• 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