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Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Endometrial Cancer

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Trial Information

Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery


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.


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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.

Outcome 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.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Gürsel Savcı, Prof.

Investigator Role:

Study Director

Investigator Affiliation:

Uludag University Faculty of Medicine

Authority:

Turkey: Ethics Committee

Study ID:

KUAP(T)-2012/39

NCT ID:

NCT01710085

Start Date:

August 2012

Completion Date:

February 2014

Related Keywords:

  • Cervical Cancer
  • Endometrial Cancer
  • Diffusion weighted MRI
  • Curative surgery
  • Recurrence
  • Body Weight
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Uterine Cervical Neoplasms
  • Adenoma

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