EndometriosisENDO-TEPNCT07053982
Use of a New Diagnostic Tool in the Detection and Characterization of Endometriosis Lesions
A study testing Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery in people with Endometriosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. [18F]-FES PET/CT could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2026to Mar 2028
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cases:
- Painful patients with a VAS ≥ 4 treated surgically for painful symptoms related to endometriosis;
- Controls:
- Patient with a VAS < 4 treated surgically for endometriosis in the context of infertility;
- Age > 18 years;
- Patient who provided informed consent;
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- Patients who underwent a preoperative MRI and were not contraindicated for [18F]-FES PET/CT;
- Patient who underwent surgery mid-cycle;
- Affiliation to a social security scheme
Who cannot join
- Patient treated for endometriosis without surgery;
- Pregnant patient
- Patient taking hormone therapy
- Menopausal patient
- Hypersensitivity to the active substance (Fluoroestradiol (18F)) or to any of the excipients
- Patient under legal protection
- Claustrophobic patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Toulouse, Rangueil Hospital
Toulouse, 65360
Ariane Weyl, +33 (0)5 61 32 21 48, weyl.a@chu-toulouse.fr
About this study
Official title: 18F]-FES PET in the Detection and Characterization of Endometriosis Lesions
Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. [18F]-FES PET/CT could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to quantify and characterize the expression of ER from diagnosis and thus helping to guide therapeutic care. We will thus attempt to correlate the intensity of [18F]-FES PET/CT with the expression of estrogen receptors and the intensity of pain.
Read the detailed description
Endometriosis is a chronic estrogen-dependent gynecological condition that leads to impaired overall quality of life due to infertility and associated pain. Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. There are several anatomo-clinical pathological entities. Thus, its painful symptoms vary greatly in its location and intensity. MRI, the reference examination for diagnosis but operator dependent, shows imperfect sensitivity. The diagnosis and characterization of lesions must therefore be improved. We know that 17β-estradiol, a key hormone for lesion growth, can also be produced locally by endometriotic tissue. The hypothesis according to which this local accumulation of estrogens plays an important role in the development of lesions by modulating the expression of RE must be studied. The use of new tools to study estrogen receptor expression should be evaluated at diagnosis. A new examination, [18F]-FES PET/CT, could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to quantify and characterize the expression of the ER from the diagnosis and thus help to guide therapeutic care. [18F]-FES PET/CT is a non-invasive, operator-independent method that visualizes and quantifies ER expression in multiple tumors. Some studies have shown that [18F]-FES uptake correlates well with ER expression measured by immunohistochemistry staining. We will thus attempt to correlate the intensity of [18F]-FES PET/CT with the expression of estrogen receptors and the intensity of pain.
- Conditions
- Endometriosis
- Being tested
- Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery
- Keywords
- Endometriosis, Estrogen receptors, Pain, [18F]-FES PET/CT
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis SurgeryProcedure or surgery
This study includes preoperative [18F]-FES PET/CT imaging to assess estrogen receptor expression in endometriosis patients undergoing laparoscopic or robot-assisted surgery. Pain levels will be evaluated using VAS, BPI, HADS, and SF-36 scales. Immunohistochemistry and quantitative mRNA expression analysis (ESR1, ESR2, GPER) will be performed on excised lesions using Tissue Microarray. This approach aims to correlate PET/CT imaging findings with histological and molecular data, distinguishing it from standard surgical interventions.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis Patients Undergoing Surgery for Severe Pain Management (EVA ≥ 4) | Experimental | Not described Receives: Procedure: Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery |
| Endometriosis Patients Undergoing Surgery for Infertility Without Severe Pain (EVA < 4) | Experimental | Not described Receives: Procedure: Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Estrogen Receptor Overexpression in Endometriotic Lesions Using SUV on [18F]-FES PET/CT
Estrogen receptor (ER) overexpression in endometriotic lesions will be assessed using the Standardized Uptake Value (SUV) on preoperative [18F]-FES PET/CT imaging. Each lesion's SUV will be quantified and compared within patients and between groups with high pain levels (VAS ≥ 4) and low or no pain (VAS < 4). ER overexpression is defined as increased [18F]-FES uptake compared to background levels. The correlation between SUV values and pain severity will be analyzed to determine whether ER overexpression is associated with symptomatic burden. Higher SUV values indicate greater ER expression.
Measured: Preoperative assessment at mid-cycle, before surgery and without concurrent hormonal treatment.
Secondary outcomes (5)
Characterization of Lesion Staining by Immunohistochemistry and In Situ Hybridization: Intensity and Receptor Expression by Anatomical Location.
Lesions were analyzed using immunohistochemistry (IHC) and in situ hybridization to characterize receptor expression patterns (ERα, ERβ, GPER) and staining intensity. Tissue microarrays (TMA) from 20 patients were used to standardize analysis. IHC staining was performed with specific antibodies against ERα (SP1) and ERβ (CWK-F12 (DSHB)), while in situ hybridization was conducted using Bio-Techne probes targeting ESR1, ESR2, and GPER mRNA. Staining intensity and receptor expression were assessed for each lesion and compared across anatomical locations. Correlation with [18F]-FES PET/CT imaging and clinical symptomatology was also evaluated.
Measured: From tissue collection at surgery to completion of immunohistochemical and in situ hybridization analyses (approximately 4 weeks post-surgery).
Sensitivity of [18F]-FES PET/CT Compared to MRI for Diagnosing Superficial and Deep Endometriotic Lesions by Anatomical Location.
The sensitivity of [18F]-FES PET/CT in detecting superficial and deep endometriotic lesions will be compared to that of MRI. Lesions will be classified based on their anatomical location. Sensitivity will be calculated as the proportion of true positive lesions detected by each imaging modality, using surgical and histopathological findings as the reference standard. The diagnostic performance of PET/CT and MRI will be analyzed for different lesion types and locations to assess their respective accuracy in detecting endometriosis.
Measured: From completion of MRI and [18F]-FES PET/CT imaging (performed within 4 weeks prior to surgery) to histopathological analysis of lesions obtained during surgery (within 4 weeks post-imaging); total assessment period: up to 8 weeks per participant
Association Between [18F]-FES SUV Intensity, Estrogen Receptor Expression (IHC), and Pain Severity (VAS Score)
The association between [18F]-FES standardized uptake value (SUV) intensity, estrogen receptor (ER) expression assessed by immunohistochemistry (IHC), and pain severity will be analyzed. ER expression will be evaluated using specific antibodies for ERα and ERβ, and quantified based on staining intensity. Pain severity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Correlations will be determined to assess the relationship between tracer uptake, receptor expression, and pain perception
Measured: From the date of [18F]-FES PET/CT imaging (≤4 weeks before surgery) to the date of surgery and completion of pain assessments (VAS and BPI) and histopathological analysis of surgical samples; total duration of assessment per participant : up to 8 weeks
Correlation Between Estrogen Receptor Expression in IHC/ISH and Pain Intensity (VAS) in Endometriosis
Estrogen receptor expression (ERα, ERβ, GPER) will be assessed in endometriotic lesions using immunohistochemistry (IHC) and in situ hybridization (ISH). Staining intensity will be scored semi-quantitatively (e.g., 0 to 3). Pain severity will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). A correlation analysis will be conducted to evaluate the relationship between receptor expression scores and VAS scores. The unit of measure will be the correlation coefficient between IHC/ISH scores and VAS units (0-10 scale).
Measured: From surgery (biopsy collection) to completion of pain assessment and histological analysis; up to 8 weeks.
Correlation Between Estrogen Receptor mRNA Expression and Pain Intensity (VAS) in Endometriosis
Estrogen receptor mRNA expression (ESR1, ESR2, GPER) will be quantified in endometriotic lesions using in situ hybridization (ISH). Expression levels will be evaluated based on signal intensity scores derived from probe hybridization. Pain severity will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain). A statistical correlation will be assessed between the mRNA expression signal intensity scores and VAS values. The unit of measure will be the correlation coefficient quantifying the relationship between receptor expression levels and reported pain intensity.
Measured: From surgery (biopsy collection) to completion of ISH and VAS assessments; up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start23 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (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.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariane WEYL, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053982
- Sponsor's protocol ID
- RC31/23/0622
- Other IDs
- 2025-520637-24-00, 2025
- Acronym
- ENDO-TEP
- Status last verified
- Mar 2026
- First submitted
- 10 Jun 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F]-FES PET in the Detection and Characterization of Endometriosis Lesions
- ClinicalTrials.gov ID
- NCT07053982
- Acronym / sponsor ID
- ENDO-TEP / RC31/23/0622
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Estrogen receptors, Pain, [18F]-FES PET/CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Jul 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.
Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. [18F]-FES PET/CT could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to quantify and characterize the expression of ER from diagnosis and thus helping to guide therapeutic care. We will thus attempt to correlate the intensity of [18F]-FES PET/CT with the expression of estrogen receptors and the intensity of pain.
Detailed description
Endometriosis is a chronic estrogen-dependent gynecological condition that leads to impaired overall quality of life due to infertility and associated pain. Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. There are several anatomo-clinical pathological entities. Thus, its painful symptoms vary greatly in its location and intensity. MRI, the reference examination for diagnosis but operator dependent, shows imperfect sensitivity. The diagnosis and characterization of lesions must therefore be improved. We know that 17β-estradiol, a key hormone for lesion growth, can also be produced locally by endometriotic tissue. The hypothesis according to which this local accumulation of estrogens plays an important role in the development of lesions by modulating the expression of RE must be studied. The use of new tools to study estrogen receptor expression should be evaluated at diagnosis. A new examination, [18F]-FES PET/CT, could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to quantify and characterize the expression of the ER from the diagnosis and thus help to guide therapeutic care. [18F]-FES PET/CT is a non-invasive, operator-independent method that visualizes and quantifies ER expression in multiple tumors. Some studies have shown that [18F]-FES uptake correlates well with ER expression measured by immunohistochemistry staining. We will thus attempt to correlate the intensity of [18F]-FES PET/CT with the expression of estrogen receptors and the intensity of pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis Patients Undergoing Surgery for Severe Pain Management (EVA ≥ 4) | Experimental | Procedure: Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery |
| Endometriosis Patients Undergoing Surgery for Infertility Without Severe Pain (EVA < 4) | Experimental | Procedure: Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Painful patients with a VAS ≥ 4 treated surgically for painful symptoms related to endometriosis;
- Patient with a VAS < 4 treated surgically for endometriosis in the context of infertility;
- Age > 18 years;
- Patient who provided informed consent;
- Patients who underwent a preoperative MRI and were not contraindicated for [18F]-FES PET/CT;
Key exclusion criteria (7 listed)
- Patient treated for endometriosis without surgery;
- Pregnant patient
- Patient taking hormone therapy
- Menopausal patient
- Hypersensitivity to the active substance (Fluoroestradiol (18F)) or to any of the excipients
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 |
|---|---|---|
| Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis SurgeryThis study includes preoperative [18F]-FES PET/CT imaging to assess estrogen receptor expression in endometriosis patients undergoing laparoscopic or robot-assisted surgery. Pain levels will be evaluated using VAS, BPI, HADS, and SF-36 scales. Immunohistochemistry and quantitative mRNA expression analysis (ESR1, ESR2, GPER) will be performed on excised lesions using Tissue Microarray. This approach aims to correlate PET/CT imaging findings with histological and molecular data, distinguishing it from standard surgical interventions. | Procedure or surgery | Endometriosis Patients Undergoing Surgery for Infertility Without Severe Pain (EVA < 4), Endometriosis Patients Undergoing Surgery for Severe Pain Management (EVA ≥ 4) |
Primary outcome
Quantification of Estrogen Receptor Overexpression in Endometriotic Lesions Using SUV on [18F]-FES PET/CT
Time frame: Preoperative assessment at mid-cycle, before surgery and without concurrent hormonal treatment.
Estrogen receptor (ER) overexpression in endometriotic lesions will be assessed using the Standardized Uptake Value (SUV) on preoperative [18F]-FES PET/CT imaging. Each lesion's SUV will be quantified and compared within patients and between groups with high pain levels (VAS ≥ 4) and low or no pain (VAS < 4). ER overexpression is defined as increased [18F]-FES uptake compared to background levels. The correlation between SUV values and pain severity will be analyzed to determine whether ER overexpression is associated with symptomatic burden. Higher SUV values indicate greater ER expression.
5 secondary outcomes
Characterization of Lesion Staining by Immunohistochemistry and In Situ Hybridization: Intensity and Receptor Expression by Anatomical Location.
Time frame: From tissue collection at surgery to completion of immunohistochemical and in situ hybridization analyses (approximately 4 weeks post-surgery).
Sensitivity of [18F]-FES PET/CT Compared to MRI for Diagnosing Superficial and Deep Endometriotic Lesions by Anatomical Location.
Time frame: From completion of MRI and [18F]-FES PET/CT imaging (performed within 4 weeks prior to surgery) to histopathological analysis of lesions obtained during surgery (within 4 weeks post-imaging); total assessment period: up to 8 weeks per participant
Association Between [18F]-FES SUV Intensity, Estrogen Receptor Expression (IHC), and Pain Severity (VAS Score)
Time frame: From the date of [18F]-FES PET/CT imaging (≤4 weeks before surgery) to the date of surgery and completion of pain assessments (VAS and BPI) and histopathological analysis of surgical samples; total duration of assessment per participant : up to 8 weeks
Correlation Between Estrogen Receptor Expression in IHC/ISH and Pain Intensity (VAS) in Endometriosis
Time frame: From surgery (biopsy collection) to completion of pain assessment and histological analysis; up to 8 weeks.
Correlation Between Estrogen Receptor mRNA Expression and Pain Intensity (VAS) in Endometriosis
Time frame: From surgery (biopsy collection) to completion of ISH and VAS assessments; up to 8 weeks.
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 25 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Ariane WEYL, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery in people with Endometriosis, run by University Hospital, Toulouse at 1 site in France.
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 9 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 25 Mar 2026. 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 France. 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 Ariane Weyl (05 61 32 21 48 ext. +33, weyl.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Estrogen Receptor Overexpression in Endometriotic Lesions Using SUV on [18F]-FES PET/CT (time frame: Preoperative assessment at mid-cycle, before surgery and without concurrent hormonal treatment.). 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 25 Mar 2026.