NCT01710085

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

October 11, 2012

Last Update Submit

October 16, 2012

Conditions

Cervical CancerEndometrial Cancer

Keywords

Diffusion weighted MRICurative surgeryRecurrence

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Study Arms (1)

Diffusion weighted imaging, Recurrence

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

Interventions

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

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.

Diffusion weighted imaging, Recurrence

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludağ Üniversitesi

Bursa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsRecurrence

Interventions

Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Gürsel Savcı, Prof.

    Uludag University

    STUDY DIRECTOR

  • Kadir Hacıkurt, Dr.

    Uludag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kadir Hacıkurt

CONTACT

+905055873273hacikurt@uludag.edu.tr

Gürsel Savcı

CONTACT

gsavci@uludag.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Kadir Hacıkurt

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 18, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

February 1, 2014

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

TU(1)