Adnexal MassesNCT02275273
Adnexal Masses : Correlation Between MRI (Magnetic Resonance Imagery) and Anatomopathology
An observational study of Adnexal Masses, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics of adnexal masses with their anatomopathological characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Masses
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Apr 2015
- 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 with adnexal masses, with a planned pelvic magnetic resonance imagery and a planned adnexectomy within the institution, having signed the informed consent form.
Who may be able to join
- Every woman aged 18 years and more, with a planned pelvic magnetic resonance imagery and a planned adnexectomy within the institution.
Who cannot join
- Insufficient technical quality of the pelvic magnetic resonance imagery images or of the anatomopathological analysis.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics of adnexal masses with their anatomopathological characteristics.
Read the detailed description
Several studies have identified the characteristics of adnexal masses obtained by different imaging techniques (echography, scanner and magnetic resonance) and corresponding to benign, borderline or malign masses (Kurtz et al 1999, Grabowska-Derlatka et al, 2013, Tanaka et al 2011, Asch et al 2008).
Recently, studies have even established ecographic and magnetic resonance imaging scores combining these characteristics (Thomassin-Naggara 2013, Timmerman 2005), some of these characteristics being considered as more suspect than others.
However, these studies have considered adnexal masses in their globality only and to our knowledge, none have correlated their imagery characteristics with their precise anatomopathology characteristics.
The goal of this study is thus to correlate the pelvic magnetic resonance imagery characteristics of the adnexal masses with their anatomopathology characteristics, in order to add complementary information for the future management of masses that are defined as borderline according to imagery.
- Conditions
- Adnexal Masses
- Keywords
- Adnexal Masses, Magnetic Resonance Imaging, Anatomopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with adnexal masses | Every patient that are at least 18 years old with a planned pelvic magnetic resonance imagery and an adnexectomy within the institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RECIST criteria
MRI imaging (standard protocol for ovarian pathology). The MRI will be realised on a 3.0T instrument (Philips Medical Systems, Best, The Netherlands). The patient will be placed in dorsal decubitus with an antenna placed at the pelvic level. Just before the examination, Buscopan IV will be injected. The initial protocol will consist in a localisation examination followed by a standard protocol for ovarian pathologies, meaning a SE T2WI in the three plans, an axial diffusion sequence and a pondered T1 sequence (T1 dynamic contrast imaging). The total examination time will be 20 minutes on average.
Measured: at MRI diagnosis
Percentage of epithelial and conjunctive zones in the adnexal mass obtained by surgery
The anatomopathologist will contact the surgeons when an adnexectomy is programmed. A detailed macroscopic description is realized (photographies of the external capsule) and the fragment is oriented according to 6 axes (superior, inferior, external, internal, anterior, posterior) with permanent tissues marking dyes. The piece will be sectioned in 1cm slices, a picture of each one being taken. The piece will be fixed in formol and embedded in paraffin. Slices will be made using a RM 2235 Leica Microtome and colored with hematoxylin/eosin, for examination by the anatomopathologist. The radiologist and the anatomopathologist will select, by consensus, interest zones that will be examined with an accredited microscope (ISO9001 accreditation). Several parameters such as the percentage of epithelial and conjunctive zones will be observed, described and semi-quantified. Immunomarkings will be realized if necessary, according to the criteria described in the ISO9001 accreditation files.
Measured: 24h after MRI diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Adnexal MassesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carine DE PREZ, Brugmann University Hospital
- Investigators
- Carine De Prez, Chef de service, Study director, CHU BrugmannFrançoise HULET, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275273
- Sponsor's protocol ID
- Adnexal masses
- Status last verified
- May 2015
- First submitted
- 27 Jun 2014
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kurtz AB, Tsimikas JV, Tempany CM, Hamper UM, Arger PH, Bree RL, Wechsler RJ, Francis IR, Kuhlman JE, Siegelman ES, Mitchell DG, Silverman SG, Brown DL, Sheth S, Coleman BG, Ellis JH, Kurman RJ, Caudry DJ, McNeil BJ. Diagnosis and staging of ovarian cancer: comparative values of Doppler and conventional US, CT, and MR imaging correlated with surgery and histopathologic analysis--report of the Radiology Diagnostic Oncology Group. Radiology. 1999 Jul;212(1):19-27. doi: 10.1148/radiology.212.1.r99jl3619.
PubMed 10405715Grabowska-Derlatka L, Derlatka P, Palczewski P, Danska-Bidzinska A, Pacho R. Differentiation of ovarian cancers from borderline ovarian tumors on the basis of evaluation of tumor vascularity in multi-row detector computed tomography--comparison with histopathology. Int J Gynecol Cancer. 2013 Nov;23(9):1597-602. doi: 10.1097/IGC.0b013e3182a80a41.
PubMed 24172096Tanaka YO, Okada S, Satoh T, Matsumoto K, Saida T, Oki A, Yoshikawa H, Minami M. Solid non-invasive ovarian masses on MR: histopathology and a diagnostic approach. Eur J Radiol. 2011 Nov;80(2):e91-7. doi: 10.1016/j.ejrad.2010.05.032. Epub 2010 Jun 23.
PubMed 20576386Asch E, Levine D, Kim Y, Hecht JL. Histologic, surgical, and imaging correlations of adnexal masses. J Ultrasound Med. 2008 Mar;27(3):327-42. doi: 10.7863/jum.2008.27.3.327.
PubMed 18314510Thomassin-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 23468574Timmerman D, Testa AC, Bourne T, Ferrazzi E, Ameye L, Konstantinovic ML, Van Calster B, Collins WP, Vergote I, Van Huffel S, Valentin L; International Ovarian Tumor Analysis Group. Logistic regression model to distinguish between the benign and malignant adnexal mass before surgery: a multicenter study by the International Ovarian Tumor Analysis Group. J Clin Oncol. 2005 Dec 1;23(34):8794-801. doi: 10.1200/JCO.2005.01.7632.
PubMed 16314639
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adnexal Masses : Correlation Between MRI (Magnetic Resonance Imagery) and Anatomopathology
- ClinicalTrials.gov ID
- NCT02275273
- Acronym / sponsor ID
- Adnexal masses
- Conditions
- Adnexal Masses
- Keywords
- Adnexal Masses, Magnetic Resonance Imaging, Anatomopathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Oct 2014 (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.
The goal of this study is to correlate the pelvic magnetic resonance imagery characteristics of adnexal masses with their anatomopathological characteristics.
Detailed description
Several studies have identified the characteristics of adnexal masses obtained by different imaging techniques (echography, scanner and magnetic resonance) and corresponding to benign, borderline or malign masses (Kurtz et al 1999, Grabowska-Derlatka et al, 2013, Tanaka et al 2011, Asch et al 2008).
Recently, studies have even established ecographic and magnetic resonance imaging scores combining these characteristics (Thomassin-Naggara 2013, Timmerman 2005), some of these characteristics being considered as more suspect than others.
However, these studies have considered adnexal masses in their globality only and to our knowledge, none have correlated their imagery characteristics with their precise anatomopathology characteristics.
The goal of this study is thus to correlate the pelvic magnetic resonance imagery characteristics of the adnexal masses with their anatomopathology characteristics, in order to add complementary information for the future management of masses that are defined as borderline according to imagery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with adnexal masses | – | –Every patient that are at least 18 years old with a planned pelvic magnetic resonance imagery and an adnexectomy within the institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with adnexal masses, with a planned pelvic magnetic resonance imagery and a planned adnexectomy within the institution, having signed the informed consent form.
Key inclusion criteria (1 listed)
- Every woman aged 18 years and more, with a planned pelvic magnetic resonance imagery and a planned adnexectomy within the institution.
Key exclusion criteria (1 listed)
- Insufficient technical quality of the pelvic magnetic resonance imagery images or of the anatomopathological analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RECIST criteria
Time frame: at MRI diagnosis
MRI imaging (standard protocol for ovarian pathology). The MRI will be realised on a 3.0T instrument (Philips Medical Systems, Best, The Netherlands). The patient will be placed in dorsal decubitus with an antenna placed at the pelvic level. Just before the examination, Buscopan IV will be injected. The initial protocol will consist in a localisation examination followed by a standard protocol for ovarian pathologies, meaning a SE T2WI in the three plans, an axial diffusion sequence and a pondered T1 sequence (T1 dynamic contrast imaging). The total examination time will be 20 minutes on average.
Percentage of epithelial and conjunctive zones in the adnexal mass obtained by surgery
Time frame: 24h after MRI diagnosis
The anatomopathologist will contact the surgeons when an adnexectomy is programmed. A detailed macroscopic description is realized (photographies of the external capsule) and the fragment is oriented according to 6 axes (superior, inferior, external, internal, anterior, posterior) with permanent tissues marking dyes. The piece will be sectioned in 1cm slices, a picture of each one being taken. The piece will be fixed in formol and embedded in paraffin. Slices will be made using a RM 2235 Leica Microtome and colored with hematoxylin/eosin, for examination by the anatomopathologist. The radiologist and the anatomopathologist will select, by consensus, interest zones that will be examined with an accredited microscope (ISO9001 accreditation). Several parameters such as the percentage of epithelial and conjunctive zones will be observed, described and semi-quantified. Immunomarkings will be realized if necessary, according to the criteria described in the ISO9001 accreditation files.
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 May 2015.
- Background: PubMed 10405715Kurtz AB, Tsimikas JV, Tempany CM, Hamper UM, Arger PH, Bree RL, Wechsler RJ, Francis IR, Kuhlman JE, Siegelman ES, Mitchell DG, Silverman SG, Brown DL, Sheth S, Coleman BG, Ellis JH, Kurman RJ, Caudry DJ, McNeil BJ. Diagnosis and staging of ovarian cancer: comparative values of Doppler and conventional US, CT, and MR imaging correlated with surgery and histopathologic analysis--report of the Radiology Diagnostic Oncology Group. Radiology. 1999 Jul;212(1):19-27. doi: 10.1148/radiology.212.1.r99jl3619.
- Background: PubMed 24172096Grabowska-Derlatka L, Derlatka P, Palczewski P, Danska-Bidzinska A, Pacho R. Differentiation of ovarian cancers from borderline ovarian tumors on the basis of evaluation of tumor vascularity in multi-row detector computed tomography--comparison with histopathology. Int J Gynecol Cancer. 2013 Nov;23(9):1597-602. doi: 10.1097/IGC.0b013e3182a80a41.
- Background: PubMed 20576386Tanaka YO, Okada S, Satoh T, Matsumoto K, Saida T, Oki A, Yoshikawa H, Minami M. Solid non-invasive ovarian masses on MR: histopathology and a diagnostic approach. Eur J Radiol. 2011 Nov;80(2):e91-7. doi: 10.1016/j.ejrad.2010.05.032. Epub 2010 Jun 23.
- Background: PubMed 18314510Asch E, Levine D, Kim Y, Hecht JL. Histologic, surgical, and imaging correlations of adnexal masses. J Ultrasound Med. 2008 Mar;27(3):327-42. doi: 10.7863/jum.2008.27.3.327.
- 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 16314639Timmerman D, Testa AC, Bourne T, Ferrazzi E, Ameye L, Konstantinovic ML, Van Calster B, Collins WP, Vergote I, Van Huffel S, Valentin L; International Ovarian Tumor Analysis Group. Logistic regression model to distinguish between the benign and malignant adnexal mass before surgery: a multicenter study by the International Ovarian Tumor Analysis Group. J Clin Oncol. 2005 Dec 1;23(34):8794-801. doi: 10.1200/JCO.2005.01.7632.
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Adnexal Masses
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.
Carine De Prez, Chef de service study director
CHU Brugmann
Françoise HULET, 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 Masses, 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 1 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 May 2015. 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?
RECIST criteria (time frame: at MRI diagnosis). The study lists 2 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 NCT02275273, which also lists 6 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 May 2015; AzTrials last refreshed its copy on 7 Nov 2026.