Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 8:41 PM
Study NCT ID:
NCT07460232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047748', 'term': 'Pituitary ACTH Hypersecretion'}, {'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062942', 'term': "2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole"}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of FET PET results in comparison to histopathology', 'timeFrame': 'Baseline', 'description': 'Percentage of cases where surgical findings and pathology are in agreement with \\[18F\\]FET-PET/MRI imaging'}, {'measure': 'Specificity of FET PET results in comparison to histopathology', 'timeFrame': 'Baseline'}, {'measure': 'Accuracy of FET PET results in comparison to histopathology', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Agreement of FET detection of ACTH-secreting pituitary with pituitary protocol MR', 'timeFrame': 'Baseline', 'description': 'Percentage of cases where pituitary protocol MR results are in agreement with FET-PET imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cushing Disease', 'Pituitary Adenoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate the performance \\[sensitivity, specificity, accuracy\\] of FET PET/CT imaging to detect ACTH-secreting pituitary adenoma, using operative findings and histopathology as truth standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet ALL criteria listed below for entry:\n\n* Biochemically diagnosed ACTH-dependent Cushing disease.\n* No previous pituitary surgery.\n* Planned to undergo pituitary surgery for localization/resection of adenoma.\n* No contraindications for PET/CT.\n* Recent (within 3 months) pituitary MR, or pending pituitary MR to be performed as close as possible to FET PET/CT.\n* Age ≥ 18 years.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential\n* Declining to use effective contraceptive methods during the study (for individuals of child-bearing potential)\n* Need for emergent surgery that would be delayed by participation\n* Bacterial, viral, or fungal infections requiring systemic therapy\n* Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator could compromise patient safety and/or protocol objectives\n* Known diagnosis of autoimmune disorders\n* Patients receiving any other investigational agent within the past 28 days\n* Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the FET injection.\n* Known hypersensitivity to any excipients used in FET'}, 'identificationModule': {'nctId': 'NCT07460232', 'briefTitle': 'FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': '18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease', 'orgStudyIdInfo': {'id': '22-006092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(ACTH)-dependent Cushing disease', 'description': 'Patients with adrenocorticotropic hormone (ACTH)-dependent Cushing disease who may be considered candidates for surgical treatment', 'interventionNames': ['Drug: Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET']}], 'interventions': [{'name': 'Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET', 'type': 'DRUG', 'description': "Patients will receive intravenous administration of radiolabeled FET (5mCi ±10%) administered 20 minutes (±10minutes) prior to the initiation of the attenuation correction CT followed by the PET acquisition encompassing the participant's head/neck, centered on the pituitary gland.", 'armGroupLabels': ['(ACTH)-dependent Cushing disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Brent Gessner, MBA', 'role': 'CONTACT', 'email': 'Gessner.Brent@mayo.edu', 'phone': '507-284-2950'}], 'overallOfficials': [{'name': 'Derek Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Derek R. Johnson', 'investigatorAffiliation': 'Mayo Clinic'}}}}