Status:
COMPLETED
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
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
NRG Oncology
Conditions:
Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 patie...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2016
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT00416455
Start Date
September 1 2007
End Date
July 16 2016
Last Update
July 23 2019
Active Locations (33)
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1
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
2
University of California at Los Angeles Health System
Los Angeles, California, United States, 90095
3
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States, 91342
4
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050