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Trial record 68 of 96 for:    gadobenate dimeglumine

MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients (ACRIN 6651)

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. Identifier: NCT00004936
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 28, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
American College of Radiology Imaging Network

Brief Summary:

RATIONALE: Imaging procedures such as MRI or CT scans may improve the ability to detect cervical cancer and determine the extent of disease.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI and CT scans in evaluating invasive cervical cancer before treatment of patients.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: iodinated contrast dye Procedure: computed tomography Procedure: magnetic resonance imaging Radiation: gadopentetate dimeglumine Not Applicable

Detailed Description:


  • Compare the diagnostic performance of magnetic resonance imaging (MRI), computed tomography (CT), and clinical FIGO staging in patients with invasive cervical cancer.
  • Compare the accuracy of MRI, CT, and clinical FIGO staging in the evaluation of morphologic tumor prognostic factors in FIGO stage IB1 and stage IB2 and greater in these patients.
  • Examine the value of imaging assessment of tumor prognostic factors (alone or in combination) as predictors of recurrence within 2 years of surgery in these patients.
  • Evaluate the quality of life in the 12-month period after staging and treatment to potentially change staging accuracy.

OUTLINE: This is a multicenter study.

Patients undergo a computed tomography scan with iodinated contrast dye followed by a magnetic resonance imaging scan with or without contrast comprising gadopentetate dimeglumine or vice versa.

Within 6 weeks of first protocol imaging study, patients undergo one of the following surgeries:

  • Laparoscopic, transabdominal, or transvaginal hysterectomy
  • Extrafascial total abdominal hysterectomy
  • Trachelectomy Quality of life is assessed at 1 and 12 months.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 465 patients will be accrued for this study within 18 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Diagnostic
Official Title: Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
Study Start Date : April 2000
Actual Primary Completion Date : May 2001
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed invasive cervical cancer, including invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma

    • FIGO stage IB1 with clinically visible gross lesion OR
    • FIGO stage IB2 or greater
  • Scheduled for one of the following surgeries at a participating Gynecological Oncology Group center:

    • Laparoscopic, transabdominal, or transvaginal hysterectomy
    • Extrafascial total abdominal hysterectomy
    • Trachelectomy
  • Not scheduled for a loop electrosurgical excision procedure or a cone biopsy only



  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No cardiac pacemakers


  • No asthma


  • Not pregnant
  • No contraindication to computed tomography (CT) (e.g., history of allergy to CT contrast medium)
  • No contraindication to magnetic resonance imaging (e.g., intracranial vascular clip)
  • No nonmalignant general medical or psychiatric condition that would preclude consent or surgery


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for invasive cervical cancer


  • See Disease Characteristics
  • No prior surgery for invasive cervical cancer


  • No prior medical treatment for invasive cervical cancer

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 identifier (NCT number): NCT00004936

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United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
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Study Chair: Hedvig Hricak, MD, PhD Memorial Sloan Kettering Cancer Center

Publications of Results:

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Responsible Party: American College of Radiology Imaging Network Identifier: NCT00004936     History of Changes
Other Study ID Numbers: CDR0000067622
CA80098 ( Other Grant/Funding Number: NCI CIP )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

Keywords provided by American College of Radiology Imaging Network:
stage III cervical cancer
stage IB cervical cancer
stage IIB cervical cancer
stage IVB cervical cancer
stage IIA cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
cervical adenocarcinoma
cervical adenosquamous cell carcinoma

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female