Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00288821
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):
W.M. Klerkx, UMC Utrecht

February 7, 2006
February 8, 2006
February 9, 2012
February 2006
March 2009   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00288821 on Archive Site
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Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology
The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in Gynaecologic Malignancies
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.
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.
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
patients with histologically proven cervical, vulvar, ovarian, endometrial cancer which are planned to have a regional lymph node dissection.
  • Cervix Neoplasms
  • Ovarian Neoplasms
  • Endometrial Neoplasms
  • Vulvar Neoplasms
  • Lymphatic Metastasis
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
DINGO study
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W.M. Klerkx, UMC Utrecht
UMC Utrecht
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Principal Investigator: A.P.M. Heintz, M.D. PhD. UMC Utrecht
Principal Investigator: W.P.Th.M. Mali, M.D. PhD. UMC Utrecht
UMC Utrecht
February 2012