The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00416455
Recruitment Status : Completed
First Posted : December 28, 2006
Results First Posted : December 14, 2015
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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 or disease Intervention/treatment 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

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Allocation: N/A
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
Study Start Date : September 2007
Actual Primary Completion Date : September 2014
Actual Study Completion Date : July 16, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen [ Time Frame: Before surgery (FDG-PET-CT) and after surgery (pathology) ]
    The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.

  2. The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.


Secondary Outcome Measures :
  1. The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis [ Time Frame: Before surgery (DCT) and after surgery (pathology) ]
    The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.

  2. The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.

  3. The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.

  4. The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.

  5. Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.

  6. Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.

  7. Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.

  8. Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.

  9. Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.

  10. Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
    The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.

  11. Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
  12. Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node [ Time Frame: Before surgery (FDG-PET/CT) and after surgery (pathology) ]
  13. Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy [ Time Frame: During surgery and up to 30 days after surgery. ]
    Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.

  14. Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients [ Time Frame: Within 4 weeks from PET/CT ]
    Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy

  15. Cause of Interruption in Radiation Therapy in Cervical Cancer Patients [ Time Frame: Within 6 weeks after surgery ]
    Number of cervical cancer patients with reasons of interruption in radiation therapy


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 33 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
NRG Oncology
Investigators
Layout table for investigator information
Principal Investigator: Mostafa Atri NRG Oncology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00416455    
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 Posted: December 28, 2006    Key Record Dates
Results First Posted: December 14, 2015
Last Update Posted: July 23, 2019
Last Verified: November 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Uterine Cervical Neoplasms
Endometrial Neoplasms
Lymphatic Metastasis
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Adenomyoepithelioma
Adenocarcinoma, Clear Cell
Cystadenocarcinoma, Serous
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasm Metastasis
 Neoplastic Processes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms