Deep EndometriosisNCT06799767
Radiological Diagnostics in Patients With Deep Endometriosis
An observational study of Deep Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Endometriosis is a benign, chronic, recurrent disease characterised by the presence of endometrial glands and stroma outside the uterine cavity. A non-negligible proportion of patients, 2-37%, are affected by deep endometriosis (DIE), defined as the pathology's involvement of the muscular tunic propria of the… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Deep Endometriosis
- How many people
- 94 participants
- Where
- 1 siteItaly
- Study dates
- 7 Apr 2021to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with a clinical and ultrasound diagnosis of deep endometriosis who are candidates for MRI for further diagnosis
Who may be able to join
- Clinical and ultrasound diagnosis of deep endometriosis, with or without ovarian endometriosis, with indication for MRI for further diagnosis and subsequent candidate for laparoscopic surgical treatment of the pathology
- Age between 18 and 40 years
- Obtaining informed consent
Who cannot join
- Previous abdominal surgery
- Personal history of malignancy (current or previous)
- Chronic inflammatory bowel disease (Crohn's disease, Ulcerative Rectocolitis, Indeterminate Colitis), interstitial cystitis
- Personal history of Pelvic Inflammatory Disease (PID), active or previous
- Previous radiotherapy/chemotherapy
- Radiculopathy, herniated discs, spinal abnormalities and pathologies
- Laparotomic conversion during surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Linda Bertoldo, MD contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Renato Seracchioli, MD, +390512143944, renato.seracchioli@aosp.bo.it
Linda Bertoldo, MD, lindabertoldodrssa@gmail.com
About this study
Official title: Implementation Of Radiological Diagnostics In Patients With Deep Endometriosis
Endometriosis is a benign, chronic, recurrent disease characterised by the presence of endometrial glands and stroma outside the uterine cavity. A non-negligible proportion of patients, 2-37%, are affected by deep endometriosis (DIE), defined as the pathology's involvement of the muscular tunic propria of the abdomino-pelvic organs.
From a therapeutic point of view, a medical or surgical approach is possible. The choice is influenced by several factors, such as the patient's age, reproductive desire, the extent of symptoms, the size and location of the endometriosis lesions, and the presence of organ damage. Although the surgical approach brings satisfactory results in terms of symptom reduction and improved fertility, the risk of complications can be very high, especially in the case of DIE, as bladder, rectal and sexual function can be compromised due to iatrogenic damage to the autonomic fibres that innervate the pelvic organs. Recently, the concept of 'nerve-sparing' surgery has been extended to gynaecology, and in particular to surgery for the treatment of endometriosis, showing encouraging results in terms of both symptom control and functional outcome.
In recent years, nuclear magnetic resonance imaging (NMR) has been increasingly helpful in the diagnosis of endometriosis and adenomyosis and is increasingly used in pre-operative planning.
Read the detailed description
Endometriosis is a benign, chronic, recurrent condition characterised by the presence of endometrial glands and stroma outside the uterine cavity. Although most frequently localised at the ovarian level (17 - 44%), a proportion of 2-37% of patients are affected by deep endometriosis (DIE), which involves the muscular tunic propria of the abdomino-pelvic organs. The most commonly affected sites are the rectovaginal septum, utero-sacral ligaments, rectum and sigma, ureters, parameters, hypogastric nerves, bladder and pre-vesical peritoneum.
In recent years, nuclear magnetic resonance imaging (NMR) has been increasingly helpful in the diagnosis of endometriosis and adenomyosis and is increasingly used in pre-operative planning together with transvaginal and/or transabdominal ultrasound. Recently, new techniques have been developed, such as Diffusion Tensor Imaging (DTI), Diffusion Weighted Imaging (DWI) and Dynamic Contrast Enhanced (DCE), whose gynaecological applications are currently in their infancy.
The study aims to evaluate the diagnostic accuracy and applicability of new MRI techniques in patients with deep endometriosis and candidates for surgical treatment.
In particular, the techniques that the investigators intend to investigate are: augmented reality, tractography, 3D-modelling, radiomics.
The use of these innovative methods, based on MRI techniques, may make it possible not only to plan an even more personalised treatment approach, selecting patients who could benefit from different treatments (such as presacral neurectomy, nerve root infiltration neurostimulation and the use of effective analgesics for neuropathic pain), but also to facilitate the localisation of endometriotic lesions during laparoscopic surgery, allowing the surgeon to assess their relationship with the main nerve and vascular structures of the pelvis and increasingly facilitating the nerve-sparing approach.
- Conditions
- Deep Endometriosis
- Keywords
- deep endometriosis, radiological diagnostics, tractography, augmented reality, 3D-modelling, radiomics
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostics and the applicability of new MRI techniques: tractography
Assessing sacral plexus root abnormalities by DTI-RMN and analysing the correlation between DTI abnormalities and the presence and severity of typical endometriosis symptoms (chronic pelvic pain, dysmenorrhoea, dyspareunia, ovulatory pain, dyschezia and dysuria) through Numerical Rating Scale (NRS), that is 0 "no pain," 10 "worst pain imaginable".
Measured: During the first visit after enrollment
Diagnostic accuracy and applicability of new MRI techniques: augmented reality
Evaluate the diagnostic accuracy and precision of fiber tractography (FT) in reconstructing the course of the ureters bilaterally and mapping the hypogastric nerve bilaterally by comparing images obtained on MRI with in vivo surgical dissection
Measured: During the first visit after enrollment
Diagnostic accuracy and applicability of new MRI techniques: 3D-modelling
Evaluate the diagnostic accuracy of 3D models of endometriosis nodules of the rectum and sigma obtained by MRI
Measured: During the first visit after enrollment
Diagnostic accuracy and applicability of new MRI techniques: radiomics
Develop a pattern-recognition system based on MRI techniques for the histological nature (stromal vs. fibrotic) of the endometriosis nodules examined. Confirmation will be obtained on the basis of the definitive histological examination after surgery
Measured: During the first visit after enrollment
Secondary outcomes (1)
Diagnostics and the applicability of new MRI techniques: tractography
Assessing the correlation between DTI abnormalities and the location of endometriotic lesions found during surgery
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start7 Apr 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato Seracchioli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799767
- Sponsor's protocol ID
- Endo-RAD
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Of Radiological Diagnostics In Patients With Deep Endometriosis
- ClinicalTrials.gov ID
- NCT06799767
- Acronym / sponsor ID
- Endo-RAD
- Conditions
- Deep Endometriosis
- Keywords
- deep endometriosis, radiological diagnostics, tractography, augmented reality, 3D-modelling, radiomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 29 Jan 2025 (actual)
- 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.
Endometriosis is a benign, chronic, recurrent disease characterised by the presence of endometrial glands and stroma outside the uterine cavity. A non-negligible proportion of patients, 2-37%, are affected by deep endometriosis (DIE), defined as the pathology's involvement of the muscular tunic propria of the abdomino-pelvic organs.
From a therapeutic point of view, a medical or surgical approach is possible. The choice is influenced by several factors, such as the patient's age, reproductive desire, the extent of symptoms, the size and location of the endometriosis lesions, and the presence of organ damage. Although the surgical approach brings satisfactory results in terms of symptom reduction and improved fertility, the risk of complications can be very high, especially in the case of DIE, as bladder, rectal and sexual function can be compromised due to iatrogenic damage to the autonomic fibres that innervate the pelvic organs. Recently, the concept of 'nerve-sparing' surgery has been extended to gynaecology, and in particular to surgery for the treatment of endometriosis, showing encouraging results in terms of both symptom control and functional outcome.
In recent years, nuclear magnetic resonance imaging (NMR) has been increasingly helpful in the diagnosis of endometriosis and adenomyosis and is increasingly used in pre-operative planning.
Detailed description
Endometriosis is a benign, chronic, recurrent condition characterised by the presence of endometrial glands and stroma outside the uterine cavity. Although most frequently localised at the ovarian level (17 - 44%), a proportion of 2-37% of patients are affected by deep endometriosis (DIE), which involves the muscular tunic propria of the abdomino-pelvic organs. The most commonly affected sites are the rectovaginal septum, utero-sacral ligaments, rectum and sigma, ureters, parameters, hypogastric nerves, bladder and pre-vesical peritoneum.
In recent years, nuclear magnetic resonance imaging (NMR) has been increasingly helpful in the diagnosis of endometriosis and adenomyosis and is increasingly used in pre-operative planning together with transvaginal and/or transabdominal ultrasound. Recently, new techniques have been developed, such as Diffusion Tensor Imaging (DTI), Diffusion Weighted Imaging (DWI) and Dynamic Contrast Enhanced (DCE), whose gynaecological applications are currently in their infancy.
The study aims to evaluate the diagnostic accuracy and applicability of new MRI techniques in patients with deep endometriosis and candidates for surgical treatment.
In particular, the techniques that the investigators intend to investigate are: augmented reality, tractography, 3D-modelling, radiomics.
The use of these innovative methods, based on MRI techniques, may make it possible not only to plan an even more personalised treatment approach, selecting patients who could benefit from different treatments (such as presacral neurectomy, nerve root infiltration neurostimulation and the use of effective analgesics for neuropathic pain), but also to facilitate the localisation of endometriotic lesions during laparoscopic surgery, allowing the surgeon to assess their relationship with the main nerve and vascular structures of the pelvis and increasingly facilitating the nerve-sparing approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with a clinical and ultrasound diagnosis of deep endometriosis who are candidates for MRI for further diagnosis
Key inclusion criteria (3 listed)
- Clinical and ultrasound diagnosis of deep endometriosis, with or without ovarian endometriosis, with indication for MRI for further diagnosis and subsequent candidate for laparoscopic surgical treatment of the pathology
- Age between 18 and 40 years
- Obtaining informed consent
Key exclusion criteria (7 listed)
- Previous abdominal surgery
- Personal history of malignancy (current or previous)
- Chronic inflammatory bowel disease (Crohn's disease, Ulcerative Rectocolitis, Indeterminate Colitis), interstitial cystitis
- Personal history of Pelvic Inflammatory Disease (PID), active or previous
- Previous radiotherapy/chemotherapy
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
Diagnostics and the applicability of new MRI techniques: tractography
Time frame: During the first visit after enrollment
Assessing sacral plexus root abnormalities by DTI-RMN and analysing the correlation between DTI abnormalities and the presence and severity of typical endometriosis symptoms (chronic pelvic pain, dysmenorrhoea, dyspareunia, ovulatory pain, dyschezia and dysuria) through Numerical Rating Scale (NRS), that is 0 "no pain," 10 "worst pain imaginable".
Diagnostic accuracy and applicability of new MRI techniques: augmented reality
Time frame: During the first visit after enrollment
Evaluate the diagnostic accuracy and precision of fiber tractography (FT) in reconstructing the course of the ureters bilaterally and mapping the hypogastric nerve bilaterally by comparing images obtained on MRI with in vivo surgical dissection
Diagnostic accuracy and applicability of new MRI techniques: 3D-modelling
Time frame: During the first visit after enrollment
Evaluate the diagnostic accuracy of 3D models of endometriosis nodules of the rectum and sigma obtained by MRI
Diagnostic accuracy and applicability of new MRI techniques: radiomics
Time frame: During the first visit after enrollment
Develop a pattern-recognition system based on MRI techniques for the histological nature (stromal vs. fibrotic) of the endometriosis nodules examined. Confirmation will be obtained on the basis of the definitive histological examination after surgery
1 secondary outcome
Diagnostics and the applicability of new MRI techniques: tractography
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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.
Linda Bertoldo, MD contact
Renato Seracchioli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Deep Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renato Seracchioli, MD (+390512143944, renato.seracchioli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostics and the applicability of new MRI techniques: tractography (time frame: During the first visit after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2025.