Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in Gynaecologic Malignancies|
|Study Start Date:||February 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288821
|University Medical Centre Utrecht|
|Utrecht, Pb 85500, Netherlands, 3508 GA|
|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|