Utility of Preoperative FDG-PET/CT and Ferumoxtran-10 MRI Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced (IB2, IIA ≥ 4 CM, IIB-IVA) Carcinoma of the Cervix or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 OR 2 Endometrioid Endometrial Carcinoma With Cervical Stromal Involvement Overt in Clinical Examination or Confirmed by Endocervical Curettage
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.
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
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
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning
Up to 5 years
Gynecologic Oncology Group
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|Sarasota Memorial Hospital||Sarasota, Florida 34239|
|University of Oklahoma Health Sciences Center||Oklahoma City, Oklahoma 73104|
|Weill Medical College of Cornell University||New York, New York 10021|
|Mount Sinai Medical Center||New York, New York 10029|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|Case Western Reserve University||Cleveland, Ohio 44106|
|Wayne State University||Detroit, Michigan 48202|
|University of Cincinnati||Cincinnati, Ohio 45267-0502|
|The Hospital of Central Connecticut||New Britain, Connecticut 06050|
|Women and Infants Hospital||Providence, Rhode Island 02905|
|UMDNJ - New Jersey Medical School||Newark, New Jersey 07103|
|Olive View-University of California Los Angeles Medical Center||Sylmar, California 91342|
|Montefiore Medical Center-Weiler Division||Bronx, New York 10461|
|Georgia Health Sciences University||Augusta, Georgia 30912|
|Jonsson Comprehensive Cancer Center||Los Angeles, California 90095|