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
NCT ID: NCT00416455
Last Updated: 2019-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
384 participants
INTERVENTIONAL
2007-09-30
2016-07-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
fludeoxyglucose F 18
Undergo FDG PET/CT
positron emission tomography
Undergo FDG PET/CT
computed tomography
Undergo FDG PET/CT
ferumoxtran-10
Undergo femoxtran-10 MRI
magnetic resonance imaging
Undergo femoxtran-10 MRI
diagnostic lymphadenectomy
Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy
lymph node biopsy
Undergo pelvic and abdominal lymph node biopsy
Interventions
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fludeoxyglucose F 18
Undergo FDG PET/CT
positron emission tomography
Undergo FDG PET/CT
computed tomography
Undergo FDG PET/CT
ferumoxtran-10
Undergo femoxtran-10 MRI
magnetic resonance imaging
Undergo femoxtran-10 MRI
diagnostic lymphadenectomy
Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy
lymph node biopsy
Undergo pelvic and abdominal lymph node biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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NRG Oncology
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Mostafa Atri
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
University of California at Los Angeles Health System
Los Angeles, California, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Georgia Regents University Medical Center
Augusta, Georgia, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States
Island Gynecologic Oncology
Brightwaters, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Providence Cancer Center -The Plaza
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
CHUQ - Pavilion Hotel-Dieu de Quebec
Québec, Quebec, Canada
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kagoshima City Hospital
Kagoshima City, Kagoshima, , Japan
Saitama Medical University International Medical Center
Saitama, , Japan
Keimyung University-Dongsan Medical Center
Jung-Ku, Daegu, South Korea
Seoul National University Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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NCI-2009-00600
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000521453
Identifier Type: -
Identifier Source: secondary_id
ACRIN 6671
Identifier Type: -
Identifier Source: secondary_id
GOG-0233/ACRIN 6671
Identifier Type: -
Identifier Source: secondary_id
GOG-0233-ACRIN 6671
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0233
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00600
Identifier Type: -
Identifier Source: org_study_id
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