Fludeoxyglucose 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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: December 27, 2006
Last updated: November 9, 2015
Last verified: July 2014
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 patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.

Condition Intervention Phase
Cervical Adenocarcinoma
Cervical Adenosquamous Cell Carcinoma
Cervical Small Cell Carcinoma
Cervical Squamous Cell Carcinoma
Endometrial Clear Cell Carcinoma
Endometrial Papillary Serous Carcinoma
Stage I Endometrial Carcinoma
Stage IB Cervical Cancer
Stage II Endometrial Carcinoma
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage III Endometrial Carcinoma
Stage IVA Cervical Cancer
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Procedure: computed tomography
Drug: ferumoxtran-10
Procedure: magnetic resonance imaging
Procedure: diagnostic lymphadenectomy
Procedure: lymph node biopsy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Utility of Preoperative FDG-PET/CT Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced Carcinoma of the Cervix (IB2, IIA ≥ 4 CM, IIB-IVA) 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percent of Patients That FDG-PET-CT Will Indicate Positive Among Those With Lymph Node Metastasis in Abdomen [ Time Frame: Before surgery (FDG-PET-CT) and after surgery (pathology) ] [ Designated as safety issue: No ]
  • Percent of Patients That DCT Will Indicate Positive Among Those With Lymph Node Metastasis in Abdomen [ Time Frame: Before surgery (DCT) and after surgery (pathology) ] [ Designated as safety issue: No ]
  • Percent of Patients That FDG-PET-CT Will Indicate Positive Among Those With Lymph Node Metastasis in Pelvis [ Time Frame: Before surgery (FDG-PET-CT) and after surgery (pathology) ] [ Designated as safety issue: No ]
  • Percent of Patients That DCT Will Indicate Positive Among Those With Lymph Node Metastasis in Pelvis [ Time Frame: Before surgery (DCT) and after surgery (pathology) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the Diagnostic Sensitivity and Specificity of PET/CT Scan vs PET Scanning Alone in Identifying Metastases to Pelvic, Abdominal, and Combined (All Regions) Lymph Nodes [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Comparison of the Diagnostic Sensitivity and Specificity of Ferumoxtran-10 MRI vs MRI Alone, in Terms of Size Criteria in the Abdomen and Pelvis [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Accuracy of MRI in Determining the Depth of Myometrial Invasion and Involvement of Cervix in Patients With High-risk Endometrial Cancer [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Complications Associated With Extraperitoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy in Patients With Locoregionally Advanced Cervical Cancer [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Cause(s) of Delay in the Initiation of Radiotherapy or Interruption in Radiotherapy in Patients With Locoregionally Advanced Cervical Cancer [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 384
Study Start Date: September 2007
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography
Undergo FDG PET/CT
Other Names:
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo FDG PET/CT
Other Name: tomography, computed
Drug: ferumoxtran-10
Undergo femoxtran-10 MRI
Other Names:
  • AMI-227
  • Combidex
  • G-53425
  • Sinerem
Procedure: magnetic resonance imaging
Undergo femoxtran-10 MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging
Procedure: diagnostic lymphadenectomy
Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy
Procedure: lymph node biopsy
Undergo pelvic and abdominal lymph node biopsy
Other Name: Biopsy of Lymph Node

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416455

  Show 33 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Mostafa Atri NRG Oncology
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00416455     History of Changes
Other Study ID Numbers: NCI-2009-00600  NCI-2009-00600  CDR0000521453  ACRIN 6671  GOG-0233/ACRIN 6671  GOG-0233-ACRIN 6671  GOG-0233  U10CA180868  U10CA027469 
Study First Received: December 27, 2006
Results First Received: November 9, 2015
Last Updated: November 9, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma, Clear Cell
Carcinoma, Adenosquamous
Carcinoma, Small Cell
Carcinoma, Squamous Cell
Cystadenocarcinoma, Serous
Endometrial Neoplasms
Small Cell Lung Carcinoma
Uterine Cervical Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Genital Diseases, Female
Genital Neoplasms, Female
Lung Diseases
Lung Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Urogenital Neoplasms
Uterine Cervical Diseases

ClinicalTrials.gov processed this record on May 26, 2016