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Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00288821
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
W.M. Klerkx, 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.

Condition or disease
Cervix Neoplasms Ovarian Neoplasms Endometrial Neoplasms Vulvar Neoplasms Lymphatic Metastasis

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.

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Study Type : Observational
Actual Enrollment : 84 participants
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
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288821


Locations
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Netherlands
University Medical Centre Utrecht
Utrecht, Pb 85500, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: A.P.M. Heintz, M.D. PhD. UMC Utrecht
Principal Investigator: W.P.Th.M. Mali, M.D. PhD. UMC Utrecht
Publications:
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Responsible Party: W.M. Klerkx, MD PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00288821    
Other Study ID Numbers: DINGO study
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012
Keywords provided by W.M. Klerkx, UMC Utrecht:
Gynaecological malignancy
Diagnostic Accuracy
DWIBS
Lymph Nodes
Metastasis
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Ovarian Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Lymphatic Metastasis
Vulvar Neoplasms
Neoplastic Processes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases
Uterine Cervical Diseases
Vulvar Diseases