Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 9:01 PM
Study NCT ID:
NCT04097535
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eric.aboagye@imperial.ac.uk', 'phone': '02083833759', 'title': 'Professor Eric Aboagye', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events were reported that had taken place up to 24 hours post injection of [18F]FPIA.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With a Suspected Cerebral Glioma on Standard of Care MRI', 'description': 'Participants was a suspected cerebral glioma on standard of care imaging that are enrolled into the study had an \\[18F\\]FPIA PET-MRI scan performed at Imanova Limited on a Signa™ 3.0 T scanner.\n\nAll participants enrolled into the study subsequently underwent a biopsy or surgical resection as part of their routine clinical care. Tissue obtained post-procedure (surgical resection/biopsy) to determine tumour grade and perform metabolomics, genomics, and proteomics.\n\nPET-MRI Protocol: Subjects received a single I.V bolus injection of \\[18F\\]FPIA followed by a saline flush. A single dose of \\[18F\\]FPIA (maximum 370MBq) was administered followed by a whole brain dynamic PET-MRI scan over 66 minutes. During the MRI sequences, the patients received an additional I.V bolus of Gadolinium contrast-medium administered through a peripheral venous cannula.\n\nMRI: Sequences for attenuation correction of PET data (DIXON, zero-TE), volumetric T1-weighted images (pre- and post-contrast administration), volumetric T2, dynamic susceptibility contrast perfusion (DSC) and dynamic contrast enhanced perfusion (DCE).\n\n* Maximum Injected Activity: 370MBq\n* Conversion Factor (mSv/MBq): 0.0187\n* Total Effective Dose (mSv)/patient: 6.9 mSv\n\nThe total effective dose for each patient in this study is 6.9 mSv. There is no ionising radiation from the MR component of the study.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With a Histologically Confirmed Grade II Glioma.', 'description': 'Participants with a suspected cerebral glioma on standard of care imaging that underwent an \\[18F\\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade II glioma.'}, {'id': 'OG001', 'title': 'Patients With a Histologically Confirmed Grade III Glioma.', 'description': 'Participants with a suspected cerebral glioma on standard of care imaging that underwent an \\[18F\\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade III glioma.'}, {'id': 'OG002', 'title': 'Patients With a Histologically Confirmed Grade IV Glioma.', 'description': 'Participants with a suspected cerebral glioma on standard of care imaging that underwent an \\[18F\\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade IV glioma.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9041', 'groupId': 'OG000', 'lowerLimit': '0.8974', 'upperLimit': '0.9108'}, {'value': '1.3529', 'groupId': 'OG001', 'lowerLimit': '1.1520', 'upperLimit': '1.5910'}, {'value': '2.0470', 'groupId': 'OG002', 'lowerLimit': '1.6564', 'upperLimit': '2.6358'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-21-0 days', 'description': 'Standardised uptake values (SUV) on \\[18F\\]FPIA PET/MRI', 'unitOfMeasure': 'SUV60_max', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation of 18F-FPIA Uptake With Tumour Type and Histological Grade Including O6-methylguanine-DNA Methyltransferase (MGMT) and Isocitrate Dehydrogenase (IDH) Gene Expression.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With a Histologically Confirmed Grade II Glioma.', 'description': 'Participants with a suspected cerebral glioma on standard of care imaging that underwent an \\[18F\\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade II glioma.'}, {'id': 'OG001', 'title': 'Patients With a Histologically Confirmed Grade III Glioma.', 'description': 'Participants with a suspected cerebral glioma on standard of care imaging that underwent an \\[18F\\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade III glioma.'}, {'id': 'OG002', 'title': 'Patients With a Histologically Confirmed Grade IV Glioma.', 'description': 'Participants with a suspected cerebral glioma on standard of care imaging that underwent an \\[18F\\]FPIA PET-MRI scan prior to routine biopsy/surgical resection. Tissue obtained post-procedure provided histological confirmation of a grade IV glioma.'}], 'classes': [{'title': 'IDH Status - IDH mutant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'IDH Status - IDH wild-type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'MGMT Status - MGMT Methylated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'MGMT Status - MGMT Unmethylated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-3 months', 'description': '\\[18F\\]FPIA PET/MRI \\& Immunohistochemistry (IHC)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Five participants enrolled into the study were patients with a histologically confirmed grade IV glioma. IDH status and MGMT status were assessed separately using immunohistochemistry (IHC) for the five participants with a grade IV glioma.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With a Suspected Cerebral Glioma on Standard of Care MRI', 'description': 'Participants with a suspected cerebral glioma on standard of care imaging that are enrolled into the study had an \\[18F\\]FPIA PET-MRI scan performed at Imanova Limited on a Signa™ 3.0 T scanner.\n\nAll participants enrolled into the study subsequently underwent a biopsy or surgical resection as part of their routine clinical care. Tissue obtained post-procedure (surgical resection/biopsy) to determine tumour grade and perform metabolomics, genomics, and proteomics.\n\nPET-MRI Protocol: Subjects received a single I.V bolus injection of \\[18F\\]FPIA followed by a saline flush. A single dose of \\[18F\\]FPIA (maximum 370MBq) was administered followed by a whole brain dynamic PET-MRI scan over 66 minutes. During the MRI sequences, the patients received an additional I.V bolus of Gadolinium contrast-medium administered through a peripheral venous cannula.\n\nMRI: Sequences for attenuation correction of PET data (DIXON, zero-TE), volumetric T1-weighted images (pre- and post-contrast administration), volumetric T2, dynamic susceptibility contrast perfusion (DSC) and dynamic contrast enhanced perfusion (DCE).\n\n* Maximum Injected Activity: 370MBq\n* Conversion Factor (mSv/MBq): 0.0187\n* Total Effective Dose (mSv)/patient: 6.9 mSv\n\nThe total effective dose for each patient in this study is 6.9 mSv. There is no ionising radiation from the MR component of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': '[18F]FPIA/radiotracer production failure - Participant subsequently withdrew consent.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was open to recruitment from the 04Jun2018 to 07Aug2020.\n\nIntervention: \\[18F\\]FPIA injection and multi-parametric, multi-modal dynamic PET-MRI performed at Imanova Limited, Burlington Danes, Imperial College London (Hammersmith Hospital Campus), Du Cane Road, London, W12 0NN.\n\nThe key objective of this study was to quantify the magnitude of the early steps fatty acid oxidation in human gliomas using \\[18F\\]FPIA PET/MRI.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With a Suspected Cerebral Glioma on Standard of Care MRI', 'description': 'Participants was a suspected cerebral glioma on standard of care imaging that are enrolled into the study had an \\[18F\\]FPIA PET-MRI scan performed at Imanova Limited on a Signa™ 3.0 T scanner.\n\nAll participants enrolled into the study subsequently underwent a biopsy or surgical resection as part of their routine clinical care. Tissue obtained post-procedure (surgical resection/biopsy) to determine tumour grade and perform metabolomics, genomics, and proteomics.\n\nPET-MRI Protocol: Subjects received a single I.V bolus injection of \\[18F\\]FPIA followed by a saline flush. A single dose of \\[18F\\]FPIA (maximum 370MBq) was administered followed by a whole brain dynamic PET-MRI scan over 66 minutes. During the MRI sequences, the patients received an additional I.V bolus of Gadolinium contrast-medium administered through a peripheral venous cannula.\n\nMRI: Sequences for attenuation correction of PET data (DIXON, zero-TE), volumetric T1-weighted images (pre- and post-contrast administration), volumetric T2, dynamic susceptibility contrast perfusion (DSC) and dynamic contrast enhanced perfusion (DCE).\n\n* Maximum Injected Activity: 370MBq\n* Conversion Factor (mSv/MBq): 0.0187\n* Total Effective Dose (mSv)/patient: 6.9 mSv\n\nThe total effective dose for each patient in this study is 6.9 mSv. There is no ionising radiation from the MR component of the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-01', 'size': 925180, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-08T09:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Brain biopsy / surgical resection tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2019-09-17', 'resultsFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2019-09-19', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-19', 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative Measurement of [18F]-FPIA Uptake in Human Gliomas', 'timeFrame': '-21-0 days', 'description': 'Standardised uptake values (SUV) on \\[18F\\]FPIA PET/MRI'}], 'secondaryOutcomes': [{'measure': 'Correlation of 18F-FPIA Uptake With Tumour Type and Histological Grade Including O6-methylguanine-DNA Methyltransferase (MGMT) and Isocitrate Dehydrogenase (IDH) Gene Expression.', 'timeFrame': '0-3 months', 'description': '\\[18F\\]FPIA PET/MRI \\& Immunohistochemistry (IHC)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/MRI', 'Fatty Acid Oxidation'], 'conditions': ['Glioma']}, 'referencesModule': {'references': [{'pmid': '37490079', 'type': 'DERIVED', 'citation': "Islam S, Inglese M, Grech-Sollars M, Aravind P, Dubash S, Barwick TD, O'Neill K, Wang J, Saleem A, O'Callaghan J, Anchini G, Williams M, Waldman A, Aboagye EO. Feasibility of [18F]fluoropivalate hybrid PET/MRI for imaging lower and higher grade glioma: a prospective first-in-patient pilot study. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):3982-3995. doi: 10.1007/s00259-023-06330-0. Epub 2023 Jul 25."}]}, 'descriptionModule': {'briefSummary': 'Glioma is the most common primary malignant brain tumour in adults and has an extremely poor prognosis. The aim of this study is to quantify the degree of early step fatty acid oxidation in gliomas as imaged by 18F-FPIA PET/MRI in 10 evaluable patients.\n\nThe Investigators hypothesise that FPIA uptake will be higher in high-grade gliomas compared to lower grade gliomas, in keeping with a higher propensity of high grade tumours to generate ATP and NADPH via fatty acid oxidation under bioenergetic stress.', 'detailedDescription': '10 evaluable participants with suspected cerebral glioma on previous MRI who are due to undergo surgical resection or biopsy will be enrolled into the study. The patients invited to participate in the study will provide full consent, but will only undergo 18F-FPIA PET/MRI imaging once they have satisfied the inclusion and exclusion criteria. Once these have been satisfied, eligible participants will proceed to 18F-FPIA PET/MRI.\n\nOn the day of imaging the participants will undergo a blood test to measure plasma concentrations of carnitine. During the scan, a single dose of 18F-FPIA (maximum, 370 MBq) IV will be administered to the participant followed by a whole brain dynamic PET/MRI scan over 66 minutes. During the MRI sequences, the participant will receive an additional IV bolus of Gadolinium contrast medium administered through a peripheral venous cannula. Arterial blood sampling through a peripheral arterial line will be performed to determine the concentration of radiotracer within arterial plasma. All the participants that are enrolled into the study will undergo biopsy or surgical resection as part of their routine clinical care, from which their tumour grade will be confirmed; the Investigators will obtain tissue from these procedures to perform metabolomics, genomics and proteomics. Surgery or biopsy will be performed typically within 2 weeks but no later than 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with radiological evidence of suspected cerebral glioma due for surgery or biopsy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with radiological evidence of suspected cerebral glioma due for surgery or biopsy and with the following characteristics will be recruited:\n\n* Age ≥18\n* Tumour size at least 2 cm.\n* WHO performance status 0 - 2.\n* If female, the subject is either post-menopausal (at least 1 year), or surgically sterilized (has had a documented bilateral oophorectomy and/or documented hysterectomy for at least 2 years,), or if of childbearing potential, must have a negative urine beta human chorionic gonadotropin pregnancy test done at initial screening and on the day of tracer administration. The result of the pregnancy test must be known before administration of 18F-FPIA injection.\n* The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained.\n* The subject has a satisfactory medical history as judged by the investigator with no significant co-morbidities, physical examination, and vital signs findings during the screening period (from 21 days before administration).\n* The subject's clinical and laboratory tests are within normal limits and/or considered clinically insignificant.\n\nExclusion\n\n* The subject has received any chemotherapy, immunotherapy, biologic therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of 18F-FPIA injection. The subject is pregnant or lactating.\n* The subject is diabetic or has uncontrolled blood glucose or blood lipid levels (clinical decision by investigator), any other chronic illness that will preclude brief discontinuation of medication, or musculoskeletal condition that would not allow comfortable performance of a 66-minute study.\n* The subject has received another investigational radioactive tracer within 1 month before administration of 18F-FPIA injection.\n* Anticoagulation therapy, prolonged prothrombin time, abnormal Allen's test.\n* Unsatisfactory renal function (eGFR\\<60)"}, 'identificationModule': {'nctId': 'NCT04097535', 'briefTitle': 'Measuring Fatty Acid Oxidation in Gliomas Using 18F-FPIA PET/MRI', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Determining the Magnitude of Early Steps of Fatty Acid Oxidation in Glioma Using 18F-FPIA', 'orgStudyIdInfo': {'id': '18HH4394'}, 'secondaryIdInfos': [{'id': '228245', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'PET/MRI', 'type': 'OTHER', 'description': 'Imaging scan'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust/ Imperial College london', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Matthew Williams, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}