[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05480995":3,"trial-entities:NCT05480995":89,"trial-summary:NCT05480995":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":42,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":70,"locations":72,"central_contacts":82,"overall_officials":83,"references":87,"see_also_links":88},"NCT05480995","22-1175","Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET \u002F MRI","Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone Positron Emission Tomography-Magnetic Resonance Imaging (PET \u002F MRI)","ACTIVE_NOT_RECRUITING","2026-08","2026-01","2026-08-28","2023-01-17","University of North Carolina, Chapel Hill","OTHER",false,"Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET\u002FMRI for diagnosis of endometriosis.\n\nParticipants: A total of 24 participants will be recruited from individuals with clinically suspected endometriosis.\n\nProcedures (methods): This is a prospective, one arm, single center study of 24 subjects with clinically suspected endometriosis to demonstrate FFNP PET-MRI's clinical utility for diagnosis of endometriosis.",null,[19],"Endometriosis",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"PHASE2",{"count":26,"type":27},9,"ACTUAL",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","18F-fluorofuranylnorprogesterone PET \u002F MRI","Subjects will receive a PET\u002FMRI with 18F-fluorofuranylnorprogesterone tracer",[31],[35,39],{"measure":36,"description":37,"timeFrame":38},"Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET\u002FMR for evaluating endometriosis","The sensitivity of FFNP PET \u002FMR is defined as the ability of readers (radiologists) to correctly detect endometriosis in patients who have endometriosis.","Upon completion of all study image data collection for all participants [approximately 1 year]",{"measure":40,"description":41,"timeFrame":38},"Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET\u002FMR for evaluating endometriosis","The specificity is similarly defined as the ability of readers to exclude endometriosis in patients who do not have it.",[43,46,49],{"measure":44,"description":45,"timeFrame":38},"Diagnostic accuracy of PET \u002FMRI","Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and\u002For by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination).",{"measure":47,"description":48,"timeFrame":38},"Correlation of uptake values (SUV-max) with Endometriosis Health Profile (EHP-30) scale controlling for covariates","Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and\u002For by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination). EHP-30 score is this is the arithmetic mean of 30 questions, each rated 0-100, about function and pain with endometriosis, where 0 indicates the best health status through to 100 worst health status. Scale scores for each scale are calculated from the total of the raw scores of each item in the scale divided by the maximum possible raw score of all the items in the scale, multiplied by 100. The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.",{"measure":50,"description":51,"timeFrame":38},"Correlation of uptake values (SUV-max) with pain level using a visual analog scale (VAS) controlling for covariates","Diagnostic accuracy will be defined by the histologic presence of endometriosis at laparotomy or laparoscopy and\u002For by symptomatic improvement as defined surgically by the referring physician within 3 months of surgery (surgeon will make final determination). The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing \"No Pain\" and 100 mm representing \"Worst Possible Pain\". The investigators will implement a random effects linear regression model, modeling SUV-max as a function of the pain rating, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.","FEMALE","18 Years","55 Years",{"inclusion":56,"exclusion":62,"raw_text":69},[57,58,59,60,61],"Age 18 or older","Female of childbearing age (18-55 years)","Clinically suspected (symptomatic) endometriosis as defined by referring physician (this would also include endometriomas as other disease may be present).","Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles","Able to provide informed consent",[63,64,65,66,67,68],"Male","Institutionalized subject (prisoner or nursing home patient)","Known history of breast, ovarian or endometrial cancer.","Pregnant or breast-feeding women","Chronic progestin-containing medications or Gonadotropin-releasing hormone (GnRH) analogues in the last 10-16 days (or 2 cycles in the case of GnRH analogues as these are dosed monthly) or inability to discontinue these medications","Allergy to gadolinium contrast or Glomerular Filtration Rate (GFR) below 30 ml\u002Fmin.","Inclusion Criteria\n\n* Age 18 or older\n* Female of childbearing age (18-55 years)\n* Clinically suspected (symptomatic) endometriosis as defined by referring physician (this would also include endometriomas as other disease may be present).\n* Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles\n* Able to provide informed consent\n\nExclusion Criteria\n\n* Male\n* Institutionalized subject (prisoner or nursing home patient)\n* Known history of breast, ovarian or endometrial cancer.\n* Pregnant or breast-feeding women\n* Chronic progestin-containing medications or Gonadotropin-releasing hormone (GnRH) analogues in the last 10-16 days (or 2 cycles in the case of GnRH analogues as these are dosed monthly) or inability to discontinue these medications\n* Allergy to gadolinium contrast or Glomerular Filtration Rate (GFR) below 30 ml\u002Fmin.",[71],"ADULT",[73],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599","United States",{"lat":80,"lon":81},35.9132,-79.05584,[],[84],{"name":85,"affiliation":13,"role":86},"Jorge Oldan, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":91},[19],[],{"nct_id":4,"found":93,"summary":94,"prompt_version":102},true,{"design":95,"status":96,"heading":6,"summary":97,"follow_up":95,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"Not specified.","completed","{\n   \"Evaluating Endometriosis with 18F-fluorofuranylnorprogesterone PET\u002FMRI\",\n   \"This study is looking at a new way to diagnose endometriosis using a special scan called 18F-fluorofuranylnorprogesterone PET\u002FMRI. This scan uses a tracer called 18F-fluorofuranylnorprogesterone to help doctors see endometriosis more clearly. The goal is to see how well this scan can find (sensitivity) and correctly identify (specificity) endometriosis. We are looking for 24 women, aged 18 to 55, who are suspected of having endometriosis and are planning to have surgery. Your participation would help us understand if this new imaging method could be a useful tool for diagnosing endometriosis in the future.\",\n  \"design\": \"This is a single-center study involving 24 participants. It is a prospective, one-arm study, meaning all participants will receive the same intervention.\",\n  \"commitments\": \"You would receive a PET\u002FMRI scan with the 18F-fluorofuranylnorprogesterone tracer. You must also be scheduled for a planned operative laparoscopy and not be on hormone treatment for at least two cycles.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"The main results will be measured upon completion of all study image data collection for all participants, which is expected to be approximately 1 year.\",\n}",188,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]