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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416455
First Posted: December 28, 2006
Last Update Posted: January 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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) ]
  • 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) ]
  • 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) ]
  • 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) ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Complications Associated With Extraperitoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy in Patients With Locoregionally Advanced Cervical Cancer [ Time Frame: Up to 5 years ]
  • 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 ]
  • Frequency and Severity of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: Up to 5 years ]

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:
  • FDG-PET
  • 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
  • USPIO
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416455


  Show 33 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000521453
ACRIN 6671
GOG-0233/ACRIN 6671
GOG-0233-ACRIN 6671 ( Other Identifier: NRG Oncology )
GOG-0233 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 27, 2006
First Posted: December 28, 2006
Results First Submitted: November 9, 2015
Results First Posted: December 14, 2015
Last Update Posted: January 2, 2017
Last Verified: November 2016

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