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

October 16, 2012 updated by: Kadir Hacikurt, Uludag University

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Bursa, Turkey
        • Recruiting
        • Uludag Universitesi
        • Contact:
        • Principal Investigator:
          • Kadir Hacıkurt
        • Principal Investigator:
          • Gürsel Savcı

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Diffusion weighted imaging, Recurrence
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uludag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gürsel Savcı, Prof., Uludag University Faculty Of Medicine
  • Principal Investigator: Kadir Hacıkurt, Dr., Uludag University Faculty Of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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

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