EndometriosisNCT06157528
Diagnosis of Pelvic Endometriosis in MRI
A study testing Magnetic resonance imaging in people with Endometriosis, run by Zhenshen Ma.
Trial summary
Purpose： Evaluate the feasibility of R2 star multiple fast gradient recalled echo (R2*MFGRE) imaging in the diagnosis of pelvic endometriosis. One hundred patients with suspected endometriosis underwent routine pelvic MRI and R2*MFGRE imaging. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to Dec 2029
- Phase
- Interventional
- 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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients who proven endometriosis by pathology Patients who wish to be treated
Who cannot join
- Received any treatment (radiotherapy, chemotherapy, surgery or chemoradiotherapy) before undergoing imaging studies poor-quality MR images with any severe motion or artifacts
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yifan Xu, MD contact
About this study
Official title: Diagnosis of Pelvic Endometriosis: a Preliminary Study on the Added Value of R2*MFGRE Sequence in MRI
Purpose： Evaluate the feasibility of R2 star multiple fast gradient recalled echo (R2*MFGRE) imaging in the diagnosis of pelvic endometriosis.
One hundred patients with suspected endometriosis underwent routine pelvic MRI and R2*MFGRE imaging. Clinical diagnosis was pathologically confirmed one month after MRI examination. Three radiologists who were blinded to the pathological results evaluated the numbers of ovarian endometriomas (OMAs) and deep in-filtrating endometriosis (DIE) lesions using routine MRI and its combination with R2*MFGRE. MRI changes of lesion size before and after estrogen therapy.
Read the detailed description
This prospective study was approved by the Ethics Committee of the local hos-pital, and informed consent was obtained from all the patients in this study (3701027061515). All procedures performed in studies involving human participants were in accordance with the ethical standards of our institutional and national re-search committee and with the Declaration of Helsinki.
Study population One hundred and Sixty-five patients with suspected endometriosis underwent pelvic MRI with R2*MFGRE imaging from Decemberr 2017 to December 2023. Of those, One hundred and forty patients were submitted to surgical (either laparotomy or laparoscopy) treatment for endometriosis. The diagnosis was confirmed by pathology within one month after the initial MR exam. Additionally, 20 out of 160 patients were excluded from the study. Of these, 11 were due to non-surgical treatment, and the other 8 were due to prominent susceptibility artifacts caused by colonic overdistention, limiting the vis-ibility of the pelvis. Finally, One hundred patients were included in the study.
All 100 patients were aged ranging from 24 to 54 years, with an average age of 37.8 years. Their clinical symptoms included dysmenorrhea, bulging in the lower abdomen or anus, heavy menstrual bleeding, dyspareunia, and infertility. Some of these patients had multiple symptoms
- Conditions
- Endometriosis
- Being tested
- Magnetic resonance imaging
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
Patients were treated with abarelix prior to the examination
| Study group | Role | What they receive |
|---|---|---|
| ovarian endometriomas | Experimental | Patients received a single dose of 1OOmg abarelix injection with slow absorption, Cmax of (43.4±32.3)ng/mL, Tmax of (3.0±2.9) days. AUC0-∞ is (500 ±96) ng·d/mL, t1/2 is (13.2±3.2) days, CL/F is (208±48) L/d Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the number of lesions
Pre- surgery, the number of lesions was counted during Magnetic resonance imaging by radiologists.
Immediately after the intervention, the number of lesions found during the operation was counted by the surgeon.
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenshen Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhenshen Ma, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157528
- Sponsor's protocol ID
- 1110000
- Status last verified
- Dec 2023
- First submitted
- 2 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Pelvic Endometriosis: a Preliminary Study on the Added Value of R2*MFGRE Sequence in MRI
- ClinicalTrials.gov ID
- NCT06157528
- Acronym / sponsor ID
- 1110000
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhenshen MaUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 Dec 2023 (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.
Purpose： Evaluate the feasibility of R2 star multiple fast gradient recalled echo (R2*MFGRE) imaging in the diagnosis of pelvic endometriosis.
One hundred patients with suspected endometriosis underwent routine pelvic MRI and R2*MFGRE imaging. Clinical diagnosis was pathologically confirmed one month after MRI examination. Three radiologists who were blinded to the pathological results evaluated the numbers of ovarian endometriomas (OMAs) and deep in-filtrating endometriosis (DIE) lesions using routine MRI and its combination with R2*MFGRE. MRI changes of lesion size before and after estrogen therapy.
Detailed description
This prospective study was approved by the Ethics Committee of the local hos-pital, and informed consent was obtained from all the patients in this study (3701027061515). All procedures performed in studies involving human participants were in accordance with the ethical standards of our institutional and national re-search committee and with the Declaration of Helsinki.
Study population One hundred and Sixty-five patients with suspected endometriosis underwent pelvic MRI with R2*MFGRE imaging from Decemberr 2017 to December 2023. Of those, One hundred and forty patients were submitted to surgical (either laparotomy or laparoscopy) treatment for endometriosis. The diagnosis was confirmed by pathology within one month after the initial MR exam. Additionally, 20 out of 160 patients were excluded from the study. Of these, 11 were due to non-surgical treatment, and the other 8 were due to prominent susceptibility artifacts caused by colonic overdistention, limiting the vis-ibility of the pelvis. Finally, One hundred patients were included in the study.
All 100 patients were aged ranging from 24 to 54 years, with an average age of 37.8 years. Their clinical symptoms included dysmenorrhea, bulging in the lower abdomen or anus, heavy menstrual bleeding, dyspareunia, and infertility. Some of these patients had multiple symptoms
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ovarian endometriomas | Experimental | Diagnostic Test: Magnetic resonance imagingPatients received a single dose of 1OOmg abarelix injection with slow absorption, Cmax of (43.4±32.3)ng/mL, Tmax of (3.0±2.9) days. AUC0-∞ is (500 ±96) ng·d/mL, t1/2 is (13.2±3.2) days, CL/F is (208±48) L/d |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients who proven endometriosis by pathology Patients who wish to be treated
Key exclusion criteria (1 listed)
- Received any treatment (radiotherapy, chemotherapy, surgery or chemoradiotherapy) before undergoing imaging studies poor-quality MR images with any severe motion or artifacts
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 |
|---|---|---|
| Magnetic resonance imagingPatients were treated with abarelix prior to the examination | Diagnostic test | ovarian endometriomas |
Primary outcome
Measuring the number of lesions
Time frame: immediately after the surgery
Pre- surgery, the number of lesions was counted during Magnetic resonance imaging by radiologists. Immediately after the intervention, the number of lesions found during the operation was counted by the surgeon.
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 6 Dec 2023.
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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.
Yifan Xu, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging in people with Endometriosis, run by Zhenshen Ma.
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: opening soon, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Zhenshen Ma, PHD (+86 13789823607, mazhenshen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the number of lesions (time frame: immediately after the surgery). 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 6 Dec 2023.