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Completed

NCT Number: NCT00004936

MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Morristown Memorial Hospital, Morristown, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iodinated contrast dye

Drug

Computed Tomography

Procedure

Magnetic Resonance Imaging

Procedure

gadopentetate dimeglumine

Radiation

Sponsors and collaborators

Lead sponsor

American College of Radiology Imaging Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer

Acronym: ACRIN 6651

Important dates

Study start
2000
Primary completion
2001
Study completion
2002
First posted
Jan 27, 2003
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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