Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology

Completed

• Conditions: Cervix Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Vulvar Neoplasms; Lymphatic Metastasis

• Registration Number: NCT00288821
• Lead Sponsor: UMC Utrecht

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-08
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University Medical Centre Utrecht; 🇳🇱 Utrecht, Pb 85500, Netherlands