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Value of Diffusion Weighted Magnetic Resonance Imaging in Detection of Recurrent Disease in Surgically Treated Cervical and Endometrial Cancer Patients

Primary Purpose

Cervical Cancer, Endometrial Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011
Sponsored by
Uludag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring Diffusion weighted MRI, Curative surgery, Recurrence

Eligibility Criteria

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

Inclusion Criteria:

  • Pathologic diagnosis of cervical or endometrial cancer.
  • Patients treated with curative surgery (hysterectomy)will be involved on a voluntary basis.

Exclusion Criteria:

  • Contraindications for MRI examination (cardiac pacemakers, metallic objects, cochlear implants, claustrophobic patients)

Sites / Locations

  • Uludağ ÜniversitesiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diffusion weighted imaging, Recurrence

Arm Description

Outcomes

Primary Outcome Measures

Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
Postoperative recurrent disease is usually investigated with physical examination, ultrasonography, computed tomography (CT), conventional magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) with different sensitivity and specificities. However, radiologists experience difficulty in detection of small recurrent active tumors with anatomically-based radiologic modalities like CT or conventional MRI in patients treated with hysterectomy. Furthermore, effects of adjuvant therapies or fibrosis developed following surgery could mask or even mimic the recurrent tumor. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2012
Last Updated
October 16, 2012
Sponsor
Uludag University
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1. Study Identification

Unique Protocol Identification Number
NCT01710085
Brief Title
Value of Diffusion Weighted Magnetic Resonance Imaging in Detection of Recurrent Disease in Surgically Treated Cervical and Endometrial Cancer Patients
Official Title
Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uludag University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Endometrial and cervical cancers are one of the most common malignancies seen in females. Identification of recurrent disease in early phases of treatment carries a primary importance on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new technique recently started to be performed in body imaging and has potential ability to detect recurrent disease. The aim of this study is to investigate the diagnostic impact of DWI in detection of recurrent disease in patients treated with curative surgery in endometrial and cervical cancer.
Detailed Description
Endometrial and cervical cancers are one of the most common malignancies seen in female genital tract. Although, surgical resection is the treatment of choice for both, adjuvant or neo-adjuvant chemotherapy or radiotherapy and curative radiotherapy are alternative treatment options depending on the stage. Identification of recurrent disease in early phases carries a primary importance on the prognosis. Diffusion-weighted MRI (DWI), a new technique recently started to be performed in body imaging has potential ability to distinguish recurrent disease from normal tissue or fibrosis. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer. All patients who had curative surgery due to endometrial or cervical cancer will be included to the study. Patients will be examined with DWI in addition to routine sequences including contrast enhanced dynamic studies. The sensitivity, specificity, accuracy as well as positive and negative predictive values of the study will be investigated from the data derived from DWI studies and will be correlated with data obtained by conventional radiologic, nuclear imaging studies including PET-CT, as well as pathologic verifications during follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer
Keywords
Diffusion weighted MRI, Curative surgery, Recurrence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diffusion weighted imaging, Recurrence
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011
Intervention Description
Recurrence in cervical and endometrial cancer patients who were treated with curative surgery is routinely investigated by MRI examination. MRI is diagnostic technique not requiring ionizing radiation and is based on magnetic fields.
Primary Outcome Measure Information:
Title
Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
Description
Postoperative recurrent disease is usually investigated with physical examination, ultrasonography, computed tomography (CT), conventional magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) with different sensitivity and specificities. However, radiologists experience difficulty in detection of small recurrent active tumors with anatomically-based radiologic modalities like CT or conventional MRI in patients treated with hysterectomy. Furthermore, effects of adjuvant therapies or fibrosis developed following surgery could mask or even mimic the recurrent tumor. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologic diagnosis of cervical or endometrial cancer. Patients treated with curative surgery (hysterectomy)will be involved on a voluntary basis. Exclusion Criteria: Contraindications for MRI examination (cardiac pacemakers, metallic objects, cochlear implants, claustrophobic patients)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kadir Hacıkurt
Phone
+905055873273
Email
hacikurt@uludag.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Gürsel Savcı
Email
gsavci@uludag.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gürsel Savcı, Prof.
Organizational Affiliation
Uludag University Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kadir Hacıkurt, Dr.
Organizational Affiliation
Uludag University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uludağ Üniversitesi
City
Bursa
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kadir Hacıkurt
Phone
+905055873273
Email
hacikurt@uludag.edu.tr
First Name & Middle Initial & Last Name & Degree
Kadir Hacıkurt
First Name & Middle Initial & Last Name & Degree
Gürsel Savcı

12. IPD Sharing Statement

Learn more about this trial

Value of Diffusion Weighted Magnetic Resonance Imaging in Detection of Recurrent Disease in Surgically Treated Cervical and Endometrial Cancer Patients

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