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Assessment of Performance of [18F]-FES for Endometriosis Diagnosis (ENDOTEP)

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ClinicalTrials.gov Identifier: NCT02233621
Recruitment Status : Terminated (not enough enrollement)
First Posted : September 8, 2014
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Endometriosis Other: [18F]FES (16α-[18F]Fluoro-17β-estradiol) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : June 2012
Actual Primary Completion Date : April 2016
Study Completion Date : April 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: PET with [18F]-FES
PET with [18F]-FES compared to histological analysis performed at least on one biopsy done during coelioscopy.
Other: [18F]FES (16α-[18F]Fluoro-17β-estradiol)
PET with [18F]FES before coelioscopy
Other Name: analog of estrogene




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233621


Locations
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France
Nuclear medicin unit, University Hospital of Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Study Chair: Philippe Descamps, PU-PH University Hospital of Angers
Principal Investigator: Olivier Couturier, PU-PH University Hospital of Angers
Principal Investigator: Céline Lefebvre-Lacoeuille, PH University Hospital of Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02233621     History of Changes
Other Study ID Numbers: 49RC10_32_01-PHRC2010-02
2011-003734-14 ( EudraCT Number )
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2014
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female