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

NCT ID: NCT01710085

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Cervical Cancer Endometrial Cancer

Keywords

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Diffusion weighted MRI Curative surgery Recurrence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Diffusion weighted imaging, Recurrence

Group Type EXPERIMENTAL

Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011

Intervention Type DEVICE

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.

Interventions

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Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Kadir Hacikurt

Dr. Kadir Hacıkurt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gürsel Savcı, Prof.

Role: STUDY_DIRECTOR

Uludag University Faculty of Medicine

Kadir Hacıkurt, Dr.

Role: PRINCIPAL_INVESTIGATOR

Uludag University Faculty of Medicine

Locations

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Uludağ Üniversitesi

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kadir Hacıkurt

Role: CONTACT

Phone: +905055873273

Email: [email protected]

Gürsel Savcı

Role: CONTACT

Email: [email protected]

Facility Contacts

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Kadir Hacıkurt

Role: primary

Other Identifiers

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KUAP(T)-2012/39

Identifier Type: -

Identifier Source: org_study_id