- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01710085
Value of Diffusion Weighted Magnetic Resonance Imaging in Detection of Recurrent Disease in Surgically Treated Cervical and Endometrial Cancer Patients
Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kadir Hacıkurt
- Phone Number: +905055873273
- Email: hacikurt@uludag.edu.tr
Study Contact Backup
- Name: Gürsel Savcı
- Email: gsavci@uludag.edu.tr
Study Locations
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Bursa, Turkey
- Recruiting
- Uludag Universitesi
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Contact:
- Kadir Hacıkurt
- Phone Number: +905055873273
- Email: hacikurt@uludag.edu.tr
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Principal Investigator:
- Kadir Hacıkurt
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Principal Investigator:
- Gürsel Savcı
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Diffusion weighted imaging, Recurrence
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.
Time Frame: 18 months
|
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.
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18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gürsel Savcı, Prof., Uludag University Faculty of Medicine
- Principal Investigator: Kadir Hacıkurt, Dr., Uludag University Faculty of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUAP(T)-2012/39
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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-
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