Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology

Sponsor
UMC Utrecht (Other)
Overall Status
Completed
CT.gov ID
NCT00288821
Collaborator
(none)
84
1
36.9
2.3

Study Details

Study Description

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.

Detailed Description

The presence of lymph node metastases indicates a poor prognosis, with a marked decrease in 5-year survival rate. Lymph node involvement is an important factor in the choice of adjuvant treatment in gynaecological malignancies. Surgical lymphadenectomy is the gold standard for the diagnosis of lymph node metastases. This is a highly specialized procedure with increase in operative time and cost, and risk of surgery-related morbidity. Therefore, a non-invasive technique that accurately identifies lymph node metastasis would be beneficial. Diffusion Weighted whole body Imaging with Background Signal suppression (DWIBS) is a new imaging technique, which lightens lymph nodes and possibly differentiates normal and hyperplastic from metastatic lymph nodes. Cancer metastases in lymph nodes may be associated with alterations in water diffusivity and microcirculation within the node. It is also likely that cell density might play an important role. So far, no feasibility studies have will be evaluated for its accuracy, effectiveness, and feasibility in detecting lymph node metastases in gynaecological malignancies, as a possible alternative for the surgical staging method. The accuracy of a pelvic lymph node dissection (reference test) will also be evaluated by performing a post-operative DWIBS scan.

Study Design

Study Type:
Observational
Actual Enrollment :
84 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in Gynaecologic Malignancies
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • Eligible for the PORTEC II trial

    • Contra-indications to the MRI: surgical clips in the brain, a pacemaker and claustrophobia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Centre Utrecht Utrecht Pb 85500 Netherlands 3508 GA

    Sponsors and Collaborators

    • UMC Utrecht

    Investigators

    • Principal Investigator: A.P.M. Heintz, M.D. PhD., UMC Utrecht
    • Principal Investigator: W.P.Th.M. Mali, M.D. PhD., UMC Utrecht

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    W.M. Klerkx, MD PhD, UMC Utrecht
    ClinicalTrials.gov Identifier:
    NCT00288821
    Other Study ID Numbers:
    • DINGO study
    First Posted:
    Feb 8, 2006
    Last Update Posted:
    Feb 9, 2012
    Last Verified:
    Feb 1, 2012

    Study Results

    No Results Posted as of Feb 9, 2012