Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.M. Klerkx, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00288821
First received: February 7, 2006
Last updated: February 8, 2012
Last verified: February 2012

February 7, 2006
February 8, 2012
February 2006
March 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00288821 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00288821
DINGO study
Not Provided
W.M. Klerkx, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: A.P.M. Heintz, M.D. PhD. University Medical Centre Utrecht
Principal Investigator: W.P.Th.M. Mali, M.D. PhD. University Medical Centre Utrecht
UMC Utrecht
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP