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
  Purpose

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.


Condition
Cervix Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Lymphatic Metastasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in Gynaecologic Malignancies

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Enrollment: 84
Study Start Date: February 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288821

Locations
Netherlands
University Medical Centre Utrecht
Utrecht, Pb 85500, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
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
  More Information

Publications:
Responsible Party: W.M. Klerkx, MD PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00288821     History of Changes
Other Study ID Numbers: DINGO study
Study First Received: February 7, 2006
Last Updated: February 8, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Gynaecological malignancy
Diagnostic Accuracy
DWIBS
Lymph Nodes
Metastasis

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Lymphatic Metastasis
Neoplasm Metastasis
Ovarian Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplastic Processes
Pathologic Processes
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Vulvar Diseases

ClinicalTrials.gov processed this record on August 28, 2014