Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

NCT00248820 | Unknown

• 1 other identifier: CT02-OV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to assess the ability of contrast-enhanced ultrasound in the detection of benign and malignant ovarian masses compared to unenhanced ultrasound. By using an intravascular contrast agent, this noninvasive and feasible imaging technique will allow the investigators to define specific microcirculation patterns in 100 women with ovarian lesions. The intravascular contrast agent properties will be compared between benign and malignant adnexal masses. The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the characterization between benign and malignant lesions.

Conditions

Ovarian Tumor

Keywords

Contrast-enhanced Ultrasound; Ultrasound Contrast agent, microbubbles; Ovarian tumor; vascularization

Outcome Measures

Primary Outcomes (1)

• From contrast-enhanced ultrasound: Enhancement parameters derived from time-intensity curves: time-to-peak, enhancement ratio, washout-time

  inclusion period

Secondary Outcomes (1)

• Histology assessments: microvessel density assessments and histological diagnosis

  inclusion period

Interventions

Contrast-enhanced ultrasound PROCEDURE

Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Patient with adnexal mass detected by ultrasound
• Any programmed surgery

You may not qualify if:

• Any contraindication to surgery
• Injection of another contrast agent within 24 hours before the study examination
• Pregnancy, breastfeeding
• Patient known to have a coronary syndrome
• Unstable angina and myocardial infarction
• Acute cardiac failure, Class III/IV cardiac failure
• Severe rhythm disorders
• Acute endocarditis
• Prosthetic valves
• Patient previously having received an investigational drug within 30 days prior to admission into this study

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital of Tours

Tours, 37044, France

RECRUITING

Related Publications (7)

• Tailor A, Jurkovic D, Bourne TH, Collins WP, Campbell S. Sonographic prediction of malignancy in adnexal masses using multivariate logistic regression analysis. Ultrasound Obstet Gynecol. 1997 Jul;10(1):41-7. doi: 10.1046/j.1469-0705.1997.10010041.x.

  PMID: 9263422 BACKGROUND

• MacSweeney JE, Cosgrove DO, Arenson J. Colour Doppler energy (power) mode ultrasound. Clin Radiol. 1996 Jun;51(6):387-90. doi: 10.1016/s0009-9260(96)80155-3. No abstract available.

  PMID: 8654001 BACKGROUND

• Timmerman D, Bourne TH, Tailor A, Collins WP, Verrelst H, Vandenberghe K, Vergote I. A comparison of methods for preoperative discrimination between malignant and benign adnexal masses: the development of a new logistic regression model. Am J Obstet Gynecol. 1999 Jul;181(1):57-65. doi: 10.1016/s0002-9378(99)70436-9.

  PMID: 10411796 BACKGROUND

• Kinkel K, Hricak H, Lu Y, Tsuda K, Filly RA. US characterization of ovarian masses: a meta-analysis. Radiology. 2000 Dec;217(3):803-11. doi: 10.1148/radiology.217.3.r00dc20803.

  PMID: 11110947 BACKGROUND

• Suren A, Osmers R, Kulenkampff D, Kuhn W. Visualization of blood flow in small ovarian tumor vessels by transvaginal color Doppler sonography after echo enhancement with injection of Levovist. Gynecol Obstet Invest. 1994;38(3):210-2. doi: 10.1159/000292481.

  PMID: 8001878 BACKGROUND

• Orden MR, Gudmundsson S, Kirkinen P. Contrast-enhanced sonography in the examination of benign and malignant adnexal masses. J Ultrasound Med. 2000 Nov;19(11):783-8. doi: 10.7863/jum.2000.19.11.783.

  PMID: 11065267 BACKGROUND

• Morel DR, Schwieger I, Hohn L, Terrettaz J, Llull JB, Cornioley YA, Schneider M. Human pharmacokinetics and safety evaluation of SonoVue, a new contrast agent for ultrasound imaging. Invest Radiol. 2000 Jan;35(1):80-5. doi: 10.1097/00004424-200001000-00009.

  PMID: 10639039 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henri Marret, PR

  Service de Gynécologie Obstétrique - Centre Olympe de Gouges CHRU Tours

  PRINCIPAL INVESTIGATOR

• François Tranquart, PR

  Centre d'Innovation Technologique - CHRU Tours

  STUDY DIRECTOR

Central Study Contacts

Henri Marret, PR

CONTACT

(33) 0 47 47 82 59; marret@med.univ-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 4, 2005
• Study Start: September 1, 2002
• Study Completion: February 1, 2009
• Last Updated: November 22, 2007

Record last verified: 2007-11

Locations

FR (1)