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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00004936
First received: March 7, 2000
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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 Intervention
Cervical Cancer
Drug: iodinated contrast dye
Procedure: computed tomography
Procedure: magnetic resonance imaging
Radiation: gadopentetate dimeglumine

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Study Start Date: April 2000
Study Completion Date: October 2002
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No cardiac pacemakers

Pulmonary:

  • No asthma

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for invasive cervical cancer

Surgery:

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

Other:

  • No prior medical treatment for invasive cervical cancer
  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: NCT00004936

Locations
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
Investigators
Study Chair: Hedvig Hricak, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00004936     History of Changes
Other Study ID Numbers: CDR0000067622, ACRIN-6651, GOG-183, CA80098
Study First Received: March 7, 2000
Last Updated: January 25, 2013
Health Authority: United States: Federal Government

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:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Gadobenic acid
Gadolinium DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2014