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

PRIMARY OBJECTIVES:

I. 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.

II. 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 OBJECTIVES:

I. 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.

II. 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.

III. 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.

IV. 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.

V. 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.

VI. Determine the accuracy of MRI in determining the depth of myometrial invasion and
involvement of cervix in patients with high-risk endometrial cancer.

VII. Determine the complications associated with extraperitoneal or laparoscopic abdominal
and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer.

VIII. Determine the cause(s) of delay in the initiation of radiotherapy or interruption in
radiotherapy in patients with locoregionally advanced cervical cancer.

IX. Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally
advanced cervical carcinoma or high-risk endometrial cancer.

X. 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.

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