Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004936
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2000-03-07
Brief Title:
MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACRIN 6651
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA80098 | OTHER_GRANT | NCI CIP | None |
| ACRIN-6651 | None | None | None |
| GOG-183 | None | None | None |