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The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in Gynaecologic Malignancies

18 Years
Not Enrolling
Cervix Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Vulvar Neoplasms, Lymphatic Metastasis

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Trial Information

The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in 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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

A.P.M. Heintz, M.D. PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Utrecht


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

DINGO study



Start Date:

February 2006

Completion Date:

March 2009

Related Keywords:

  • Cervix Neoplasms
  • Ovarian Neoplasms
  • Endometrial Neoplasms
  • Vulvar Neoplasms
  • Lymphatic Metastasis
  • Gynaecological malignancy
  • Diagnostic Accuracy
  • Lymph Nodes
  • Metastasis
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Lymphatic Metastasis
  • Neoplasm Metastasis
  • Ovarian Neoplasms
  • Vulvar Neoplasms
  • Adenoma