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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iodinated contrast dye
computed tomography
magnetic resonance imaging
gadopentetate dimeglumine
Sponsored by
American College of Radiology Imaging Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Morristown Memorial Hospital
  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
January 25, 2013
Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004936
Brief Title
MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients
Acronym
ACRIN 6651
Official Title
Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
May 2001 (Actual)
Study Completion Date
October 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American College of Radiology Imaging Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
iodinated contrast dye
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Radiation
Intervention Name(s)
gadopentetate dimeglumine

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedvig Hricak, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962-1956
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19019414
Citation
Mitchell DG, Snyder B, Coakley F, Reinhold C, Thomas G, Amendola MA, Schwartz LH, Woodward P, Pannu H, Atri M, Hricak H. Early invasive cervical cancer: MRI and CT predictors of lymphatic metastases in the ACRIN 6651/GOG 183 intergroup study. Gynecol Oncol. 2009 Jan;112(1):95-103. doi: 10.1016/j.ygyno.2008.10.005. Epub 2008 Nov 20.
Results Reference
result
PubMed Identifier
17940305
Citation
Hricak H, Gatsonis C, Coakley FV, Snyder B, Reinhold C, Schwartz LH, Woodward PJ, Pannu HK, Amendola M, Mitchell DG. Early invasive cervical cancer: CT and MR imaging in preoperative evaluation - ACRIN/GOG comparative study of diagnostic performance and interobserver variability. Radiology. 2007 Nov;245(2):491-8. doi: 10.1148/radiol.2452061983.
Results Reference
result
PubMed Identifier
17179104
Citation
Mitchell DG, Snyder B, Coakley F, Reinhold C, Thomas G, Amendola M, Schwartz LH, Woodward P, Pannu H, Hricak H. Early invasive cervical cancer: tumor delineation by magnetic resonance imaging, computed tomography, and clinical examination, verified by pathologic results, in the ACRIN 6651/GOG 183 Intergroup Study. J Clin Oncol. 2006 Dec 20;24(36):5687-94. doi: 10.1200/JCO.2006.07.4799.
Results Reference
result
PubMed Identifier
16234512
Citation
Amendola MA, Hricak H, Mitchell DG, Snyder B, Chi DS, Long HJ 3rd, Fiorica JV, Gatsonis C. Utilization of diagnostic studies in the pretreatment evaluation of invasive cervical cancer in the United States: results of intergroup protocol ACRIN 6651/GOG 183. J Clin Oncol. 2005 Oct 20;23(30):7454-9. doi: 10.1200/JCO.2004.00.5397.
Results Reference
result
PubMed Identifier
16361632
Citation
Hricak H, Gatsonis C, Chi DS, Amendola MA, Brandt K, Schwartz LH, Koelliker S, Siegelman ES, Brown JJ, McGhee RB Jr, Iyer R, Vitellas KM, Snyder B, Long HJ 3rd, Fiorica JV, Mitchell DG; American College of Radiology Imaging Network 6651; Gynecologic Oncology Group 183. Role of imaging in pretreatment evaluation of early invasive cervical cancer: results of the intergroup study American College of Radiology Imaging Network 6651-Gynecologic Oncology Group 183. J Clin Oncol. 2005 Dec 20;23(36):9329-37. doi: 10.1200/JCO.2005.02.0354.
Results Reference
result

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

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