Adnexal TumorNCT02742870
Diffusion MRI (Magnetic Resonance Imaging) Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness
An observational study of Adnexal Tumor, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Tumor
- What is being tested?
- Correlation of MRI results with clinical characteristics of the adnexal mass
- How many people
- 126 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Mar 2016to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.
Who may be able to join
- Women aged over 18 years old, having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.
Who cannot join
- Examinations without diffusion sequences
- Examinations with incomplete diffusion sequences
- Absence of anato-pathologic result, or absence of gynecological clinical/imaging follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diffusion Magnetic Resonance Imaging Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness
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.
Read more
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.
- Conditions
- Adnexal Tumor
- Being tested
- Correlation of MRI results with clinical characteristics of the adnexal mass
- Keywords
- Diffusion MRI, ADC histograms, Adnexal tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlation of MRI results with clinical characteristics of the adnexal massOther
Quantitative analysis of the magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens), based on the ADC cartography.The post-processing will be realized with the Syngo Onco Care application of Siemens, that allows an histogram analysis of the ADC of all sections of the adnexal mass, as opposed to a section per section approach with the Region of Interest (ROI) method.
The results will be correlated with the clinical data regarding the adnexal mass: anatomo-pathology status (malignancy and aggressiveness of the tumor) and the gynecological follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MRI pelvic imaging | Women over 18 years old, having undergone a magnetic resonance imaging of the pelvis within the CHU Brugmann Hospital Receives: Other: Correlation of MRI results with clinical characteristics of the adnexal mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec)
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Measured: From 01/01/2015 till the end of study (2 years)
Anatomo-pathology classification - histological type
Follow-up of the patients that did undergo surgery: histological type of tumor. The histological type of the tumor will be determined by the Anatomo-Pathology Department of the CHU Brugmann hospital, according to standard of care.
Measured: From 01/01/2015 till the end of study (2 years)
MRI Adnex score
Follow-up of the patients that did not undergo surgery: medical imaging classification of the adnexal mass (MRI Adnex score)
Measured: From 01/01/2015 till the end of study (2 years)
IOTA ultrasound classification
Follow-up of the patients that did not undergo surgery: transvaginal ultrasound classification of the adnexal masse (IOTA ultrasound classification)
Measured: From 01/01/2015 till the end of study (2 years)
Anatomo-pathology classification - malignancy grading of tumor
Follow-up of the patients that did undergo surgery: malignancy grading of the adnexal mass according to FIGO classification.
Measured: From 01/01/2015 till the end of study (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start8 Mar 2016
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adnexal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mieke Cannie, Brugmann University Hospital
- Investigators
- Mieke Cannie, MD, Principal investigator, CHU BrugmannNathalie Hottat, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742870
- Sponsor's protocol ID
- CHUB-MRI-Adnexal Tumor
- Status last verified
- Jan 2020
- First submitted
- 1 Apr 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Thomassin-Naggara I, Aubert E, Rockall A, Jalaguier-Coudray A, Rouzier R, Darai E, Bazot M. Adnexal masses: development and preliminary validation of an MR imaging scoring system. Radiology. 2013 May;267(2):432-43. doi: 10.1148/radiol.13121161. Epub 2013 Mar 6.
PubMed 23468574Just N. Improving tumour heterogeneity MRI assessment with histograms. Br J Cancer. 2014 Dec 9;111(12):2205-13. doi: 10.1038/bjc.2014.512. Epub 2014 Sep 30.
PubMed 25268373
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Magnetic Resonance Imaging Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness
- ClinicalTrials.gov ID
- NCT02742870
- Acronym / sponsor ID
- CHUB-MRI-Adnexal Tumor
- Conditions
- Adnexal Tumor
- Keywords
- Diffusion MRI, ADC histograms, Adnexal tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with MRI pelvic imaging | – | Other: Correlation of MRI results with clinical characteristics of the adnexal massWomen over 18 years old, having undergone a magnetic resonance imaging of the pelvis within the CHU Brugmann Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.
Key inclusion criteria (1 listed)
- Women aged over 18 years old, having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.
Key exclusion criteria (3 listed)
- Examinations without diffusion sequences
- Examinations with incomplete diffusion sequences
- Absence of anato-pathologic result, or absence of gynecological clinical/imaging follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correlation of MRI results with clinical characteristics of the adnexal massQuantitative analysis of the magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens), based on the ADC cartography.The post-processing will be realized with the Syngo Onco Care application of Siemens, that allows an histogram analysis of the ADC of all sections of the adnexal mass, as opposed to a section per section approach with the Region of Interest (ROI) method. The results will be correlated with the clinical data regarding the adnexal mass: anatomo-pathology status (malignancy and aggressiveness of the tumor) and the gynecological follow-up. | Other | Patients with MRI pelvic imaging |
Primary outcome
Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec)
Time frame: From 01/01/2015 till the end of study (2 years)
Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Anatomo-pathology classification - histological type
Time frame: From 01/01/2015 till the end of study (2 years)
Follow-up of the patients that did undergo surgery: histological type of tumor. The histological type of the tumor will be determined by the Anatomo-Pathology Department of the CHU Brugmann hospital, according to standard of care.
MRI Adnex score
Time frame: From 01/01/2015 till the end of study (2 years)
Follow-up of the patients that did not undergo surgery: medical imaging classification of the adnexal mass (MRI Adnex score)
IOTA ultrasound classification
Time frame: From 01/01/2015 till the end of study (2 years)
Follow-up of the patients that did not undergo surgery: transvaginal ultrasound classification of the adnexal masse (IOTA ultrasound classification)
Anatomo-pathology classification - malignancy grading of tumor
Time frame: From 01/01/2015 till the end of study (2 years)
Follow-up of the patients that did undergo surgery: malignancy grading of the adnexal mass according to FIGO classification.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 23468574Thomassin-Naggara I, Aubert E, Rockall A, Jalaguier-Coudray A, Rouzier R, Darai E, Bazot M. Adnexal masses: development and preliminary validation of an MR imaging scoring system. Radiology. 2013 May;267(2):432-43. doi: 10.1148/radiol.13121161. Epub 2013 Mar 6.
- Background: PubMed 25268373Just N. Improving tumour heterogeneity MRI assessment with histograms. Br J Cancer. 2014 Dec 9;111(12):2205-13. doi: 10.1038/bjc.2014.512. Epub 2014 Sep 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mieke Cannie, MD principal investigator
CHU Brugmann
Nathalie Hottat, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Tumor, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec) (time frame: From 01/01/2015 till the end of study (2 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742870, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.