NCT00288821

Brief Summary

The purpose of the study is to determine the diagnostic accuracy of a new magnetic resonance imaging (MRI) technique, the diffusion weighted imaging with body background signal suppression (DWIBS) in the detection of lymph node pathology in patients with gynaecologic malignancies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 9, 2012

Status Verified

February 1, 2012

Enrollment Period

3.1 years

First QC Date

February 7, 2006

Last Update Submit

February 8, 2012

Conditions

Cervix NeoplasmsOvarian NeoplasmsEndometrial NeoplasmsVulvar NeoplasmsLymphatic Metastasis

Keywords

Gynaecological malignancyDiagnostic AccuracyDWIBSLymph NodesMetastasis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with histologically proven cervical, vulvar, ovarian, endometrial cancer which are planned to have a regional lymph node dissection.

You may qualify if:

  • Patients with
  • Cervical cancer stage Ia2-Ib, IIa
  • Endometrial cancer stage I (high risk), II
  • Ovarian cancer stage I, IIa-IIa
  • Vulvar cancer stage I, II
  • Age \> 18 years
  • Karnofsky score \> 70

You may not qualify if:

  • Eligible for the PORTEC II trial
  • Contra-indications to the MRI: surgical clips in the brain, a pacemaker and claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Utrecht

Utrecht, Pb 85500, 3508 GA, Netherlands

Location

Related Publications (1)

  • Takahara T, Imai Y, Yamashita T, Yasuda S, Nasu S, Van Cauteren M. Diffusion weighted whole body imaging with background body signal suppression (DWIBS): technical improvement using free breathing, STIR and high resolution 3D display. Radiat Med. 2004 Jul-Aug;22(4):275-82.

    PMID: 15468951BACKGROUND

MeSH Terms

Conditions

Uterine Cervical NeoplasmsOvarian NeoplasmsEndometrial NeoplasmsVulvar NeoplasmsLymphatic MetastasisNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersVulvar DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • A.P.M. Heintz, M.D. PhD.

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • W.P.Th.M. Mali, M.D. PhD.

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 8, 2006

Study Start

February 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 9, 2012

Record last verified: 2012-02

Locations

NL(1)