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NCT02742870
Diffusion MRI (Magnetic Resonance Imaging) Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness
trial testing Correlation of MRI results with clinical characteristics of the adnexal mass in Adnexal Tumor in 126 participants. Completed in 30 January 2019.
30 January 2019
Quick facts
| Lead sponsor | Brugmann University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 126 |
| Start date | 8 March 2016 |
| Primary completion | 30 January 2019 |
| Estimated completion | 30 January 2019 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Correlation of MRI results with clinical characteristics of the adnexal mass
Conditions studied
- Adnexal Tumor — all drugs for Adnexal Tumor →
Sponsor
Brugmann University Hospital
Who can join
18 and older, female only, with Adnexal Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Diffusion-weighted sequences have been routinely performed for years to study the pelvis. They have been so far mainly qualitatively interpreted, that is to say as the absence or presence of an hypersignal at a high b value. The quantitative analysis involves placing the region of interest (ROI) on the apparent diffusion coefficient (ADC) map. The manual placement is very operator dependent, and does not reflect the entirety of the studied mass. In all fields of Magnetic Resonance Imaging, a multiparametric approach integrating diffusion analysis is flourishing. However, the quantitative analysis of the diffusion is still little studied for tumor heterogeneity analysis, including in the gynecological sphere. The investigators will therefore retrospectively evaluate the apparent diffusion coefficient (ADC) histograms, extracted from the diffusion ponderation sequences, of the magnetic imaging resonance analysis of adnexal masses and confront the results with the anatomo-pathology results, for patients having undergone surgery, and/or with the clinical and imagery follow-up results. The investigators goal will be to improve the performance of conventional MRI in the analysis of adnexal masses. The expected benefits of this study are: * a correlation with the histology analysis or the clinical monitoring * an improved prediction of the malignancy of the tumor * an improved magnetic resonance imaging performance for adnexal masses, with better surgical therapeutic management * an improved negative predictive value, thereby ultimately limiting unnecessary surgical explorations.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02742870
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02742870 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brugmann University Hospital
- Last refreshed: 18 January 2020
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