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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Notify MeKey information
Conditions
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Morristown Memorial Hospital, Morristown, New Jersey, United States
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
Computed Tomography
ProcedureMagnetic Resonance Imaging
Proceduregadopentetate dimeglumine
RadiationSponsors 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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