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

American College of Radiology Imaging Network

Status: Completed

Conditions: Cervical Cancer

Treatments: Drug: iodinated contrast dye; Radiation: gadopentetate dimeglumine; Procedure: magnetic resonance imaging; Procedure: computed tomography

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00004936

ACRIN-6651

CA80098 (Other Grant/Funding Number)

GOG-183

CDR0000067622

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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