EndometriosisPhase 2ENDOTEPNCT02233621
Assessment of Performance of [18F]-FES for Endometriosis Diagnosis
A Phase 2 study testing [18F]FES (16α-[18F]Fluoro-17β-estradiol) in people with Endometriosis, run by University Hospital, Angers at 1 site in France.
Trial summary
Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of the main problem of endometriosis is the significant delay of diagnosis.This delay has significant consequences for patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- [18F]FES (16α-[18F]Fluoro-17β-estradiol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to 6 Apr 2016
- Phase
- Phase 2
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- First planned coelioscopy (therapeutic indication) for suspected endometriosis
- Patient aged from 18 to 50 years
- Absence of treatment with GnRH (gonadotropin-releasing hormone) analogue for at least 3 months
- Patient affiliated to a social security system
- No hormonal treatment for at least 3 months
Who cannot join
- History of abdominal pelvic surgery for endometriosis
- Current treatment with GnRH (gonadotropin-releasing hormone) or stopped for less than 3 months
- hormonal Drug ongoing
- Patient pregnant, may be or during lactation
- Patient under guardianship or trusteeship
- Patient unable to understand the purpose of the study
- Patient already included in another clinical trial with an experimental molecule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Des Performances de la Tomographie Par Emission de Positons Avec la 16α-[18F]Fluoro-17β-estradiol ([18F]-FES) Pour le Diagnostic de l'Endometriose
Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of the main problem of endometriosis is the significant delay of diagnosis.This delay has significant consequences for patients. Currently the definitive diagnosis of endometriosis and the evaluation of its lesional extension require performing laparoscopy and a histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose development and growth are estrogen-dependent, express estrogen receptor (ER). [18F]FES (16α-[18F]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this functional imaging as a diagnostic tool for endometriosis.
The aim of this multicenter, prospective, open study is to assess sensitivity of PET with [18F] -FES for diagnosing endometriosis compared to the gold standard (histological confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for suspected endometriosis and for whom laparoscopy is already scheduled.
- Conditions
- Endometriosis
- Being tested
- [18F]FES (16α-[18F]Fluoro-17β-estradiol)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FES (16α-[18F]Fluoro-17β-estradiol)Other
Also called analog of estrogene
PET with [18F]FES before coelioscopy
| Study group | Role | What they receive |
|---|---|---|
| PET with [18F]-FES | Experimental | PET with [18F]-FES compared to histological analysis performed at least on one biopsy done during coelioscopy. Receives: Other: [18F]FES (16α-[18F]Fluoro-17β-estradiol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of PET with [18F] -FES for diagnosing endometriosis defined by the ability of this diagnostic exam to give a positive result when endometriosis is present
PET with [18F]-FES considered positive if it allows to identify at least one hyperfixation area in a physiologically area not fixing tracer or not corresponding to a physiological removal area tracer.
PET results will be correlated with The results of PET with [18F] -FES will be correlated with histology results of at least one of the biopsies performed at laparoscopy.
Measured: Within 3 months after inclusion when laparoscopy is already scheduled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJun 2012
- Primary completionApr 2016
- Study completion6 Apr 2016
Why it stopped: not enough enrollement
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, AngersThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Philippe Descamps, PU-PH, Study chair, University Hospital of AngersOlivier Couturier, PU-PH, Principal investigator, University Hospital of AngersCéline Lefebvre-Lacoeuille, PH, Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233621
- Sponsor's protocol ID
- 49RC10_32_01-PHRC2010-02
- Other IDs
- 2011-003734-14
- Acronym
- ENDOTEP
- Status last verified
- Sep 2014
- First submitted
- 29 Aug 2014
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Des Performances de la Tomographie Par Emission de Positons Avec la 16α-[18F]Fluoro-17β-estradiol ([18F]-FES) Pour le Diagnostic de l'Endometriose
- ClinicalTrials.gov ID
- NCT02233621
- Acronym / sponsor ID
- ENDOTEP / 49RC10_32_01-PHRC2010-02
- Conditions
- Endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough enrollement
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- 6 Apr 2016
- First posted
- 8 Sep 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.
Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of the main problem of endometriosis is the significant delay of diagnosis.This delay has significant consequences for patients. Currently the definitive diagnosis of endometriosis and the evaluation of its lesional extension require performing laparoscopy and a histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose development and growth are estrogen-dependent, express estrogen receptor (ER). [18F]FES (16α-[18F]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this functional imaging as a diagnostic tool for endometriosis.
The aim of this multicenter, prospective, open study is to assess sensitivity of PET with [18F] -FES for diagnosing endometriosis compared to the gold standard (histological confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for suspected endometriosis and for whom laparoscopy is already scheduled.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET with [18F]-FES | Experimental | Other: [18F]FES (16α-[18F]Fluoro-17β-estradiol)PET with [18F]-FES compared to histological analysis performed at least on one biopsy done during coelioscopy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- First planned coelioscopy (therapeutic indication) for suspected endometriosis
- Patient aged from 18 to 50 years
- Absence of treatment with GnRH (gonadotropin-releasing hormone) analogue for at least 3 months
- Patient affiliated to a social security system
- No hormonal treatment for at least 3 months
Key exclusion criteria (7 listed)
- History of abdominal pelvic surgery for endometriosis
- Current treatment with GnRH (gonadotropin-releasing hormone) or stopped for less than 3 months
- hormonal Drug ongoing
- Patient pregnant, may be or during lactation
- Patient under guardianship or trusteeship
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 |
|---|---|---|
| [18F]FES (16α-[18F]Fluoro-17β-estradiol)Also: analog of estrogenePET with [18F]FES before coelioscopy | Other | PET with [18F]-FES |
Primary outcome
sensitivity of PET with [18F] -FES for diagnosing endometriosis defined by the ability of this diagnostic exam to give a positive result when endometriosis is present
Time frame: Within 3 months after inclusion when laparoscopy is already scheduled.
PET with [18F]-FES considered positive if it allows to identify at least one hyperfixation area in a physiologically area not fixing tracer or not corresponding to a physiological removal area tracer. PET results will be correlated with The results of PET with [18F] -FES will be correlated with histology results of at least one of the biopsies performed at laparoscopy.
Results and safety
The study was stopped early (reason given: not enough enrollement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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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.
Philippe Descamps, PU-PH study chair
University Hospital of Angers
Olivier Couturier, PU-PH principal investigator
University Hospital of Angers
Céline Lefebvre-Lacoeuille, PH principal investigator
University Hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]FES (16α-[18F]Fluoro-17β-estradiol) in people with Endometriosis, run by University Hospital, Angers 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 5 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: stopped early, as of the sponsor's last update on 17 Sep 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: not enough enrollement). Results are not available in the source record.
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?
sensitivity of PET with [18F] -FES for diagnosing endometriosis defined by the ability of this diagnostic exam to give a positive result when endometriosis is present (time frame: Within 3 months after inclusion when laparoscopy is already scheduled.). 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 17 Sep 2018.