Clinical trial NCT00288821: Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology
Official title: The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in Gynaecologic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Lymphatic Metastasis
Keywords: Gynaecological malignancy
Diagnostic Accuracy
DWIBS
Lymph Nodes
Metastasis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2006-02-08
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with histologically proven cervical, vulvar, ovarian, endometrial cancer which are planned to have a regional lymph node dissection.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
state: Pb 85500
Study officials:
affiliation: UMC Utrecht
name: A.P.M. Heintz, M.D. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: W.P.Th.M. Mali, M.D. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.