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
Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma
About this trial
This is an interventional diagnostic trial for Cervical Adenocarcinoma
Eligibility 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
Sites / Locations
- Jonsson Comprehensive Cancer Center
- University of California at Los Angeles Health System
- Olive View-University of California Los Angeles Medical Center
- The Hospital of Central Connecticut
- Sarasota Memorial Hospital
- Georgia Regents University Medical Center
- Massachusetts General Hospital Cancer Center
- Wayne State University/Karmanos Cancer Institute
- Mayo Clinic
- UMDNJ - New Jersey Medical School
- Island Gynecologic Oncology
- Montefiore Medical Center-Einstein Campus
- Mount Sinai Medical Center
- Weill Medical College of Cornell University
- Carolinas Medical Center
- University of Cincinnati
- Case Western Reserve University
- University of Oklahoma Health Sciences Center
- Providence Cancer Center -The Plaza
- Providence Portland Medical Center
- Fox Chase Cancer Center
- Women and Infants Hospital
- Vanderbilt-Ingram Cancer Center
- Brooke Army Medical Center
- CHUQ - Pavilion Hotel-Dieu de Quebec
- Hokkaido University Hospital
- Kagoshima City Hospital
- Saitama Medical University International Medical Center
- Keimyung University-Dongsan Medical Center
- Seoul National University Hospital
- Gangnam Severance Hospital
- Asan Medical Center
- Korea Cancer Center Hospital
Arms of the Study
Arm 1
Experimental
Treatment (diagnostic scans, surgery, chemotherapy, radiation)
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.