Diagnostic Imaging of Lymph Nodes in Gynaecologic Oncology

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288821
• Other study ID #: DINGO study
• Status: Completed
• Phase: N/A
• First received: February 7, 2006
• Last updated: February 8, 2012
• Start date: February 2006
• Est. completion date: March 2009

Study information

• Verified date: February 2012
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervix Neoplasms
• Endometrial Neoplasms
• Lymphatic Metastasis
• Neoplasms
• Ovarian Neoplasms
• Uterine Cervical Neoplasms
• Vulvar Neoplasms

Locations

Country	Name	City	State
Netherlands	University Medical Centre Utrecht	Utrecht	Pb 85500

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation