Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-07 @ 11:10 AM
Study NCT ID:
NCT03294434
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2017-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Sites of Tumour Progression in the Invasive Margin of Glioblastomas (PRaM-GBM Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}], 'ancestors': [{'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Patients that consent to participate in the optional PET sub-study will consent to the collection of additional tissue biopsies to be taken at the time of their standard of care surgery.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-26', 'studyFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2017-09-22', 'lastUpdatePostDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference of area highlighted by amino-acid PET and DTI-MRI', 'timeFrame': '18 months', 'description': 'Investigate the relationship between amino-acid PET, area of surgical resection and the area highlighted by DTI-MRI'}, {'measure': 'Number of amino-acid PET only image guided biopsies taken from patients', 'timeFrame': '18 months', 'description': 'Investigate the feasibility of taking image-guided biopsies from patients in the region outside of the area with increased amino-acid PET uptake'}, {'measure': 'Site of glioblastoma true progression correctly predicted from pre-operative imaging by a region that is predicted by the DTI abnormality outside of the area of increased uptake to amino-acid on PET', 'timeFrame': '18 months', 'description': 'Explore the extent of invasive disease (from DTI/perfusion) that is likely to be left following surgery by assessing potential resected tumour using amino acid PET'}], 'primaryOutcomes': [{'measure': 'Site of glioblastoma true progression correctly predicted by DTI scan', 'timeFrame': '18 months', 'description': 'Assess the diagnostic accuracy of DTI at pre-surgery or/and pre-radiotherapy as a biomarker to predict site of glioblastoma progression'}], 'secondaryOutcomes': [{'measure': 'Accuracy of DTI as a biomarker', 'timeFrame': '18 months', 'description': 'Explore difference of DTI performed pre-surgery and pre-radiotherapy to predict the site of glioblastoma progression'}, {'measure': 'Perfusion imaging', 'timeFrame': '18 months', 'description': 'Investigate dynamic susceptibility imaging to measure rCBV of the invasive margin to improve the accuracy of the DTI biomarker.'}, {'measure': 'Time to progression', 'timeFrame': '18 months', 'description': 'Investigate if pattern of invasion can predict time to progression'}, {'measure': 'Extent of resection and volume of tumour that remains post-surgery by standard imaging and DTI', 'timeFrame': '18 months', 'description': 'Determine the effect of resection on the invasive margin as determined by DTI'}, {'measure': 'Radiotherapy dose according to DTI-defined invasive region', 'timeFrame': '18 months', 'description': 'Retrospectively compare dose of radiotherapy using the DTI-defined invasive region receives with conventional radiotherapy plans'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Grade Glioma']}, 'descriptionModule': {'briefSummary': 'Brain tumours are the leading cause of cancer deaths in children, men under the age of 45 and women under the age of 25. Glioblastoma is the most common and most malignant primary tumour. The predominant treatment is surgical removal of the tumour followed by radiotherapy. Sadly the majority of patients given this treatment develop recurrent and progressive disease.\n\nBetter understanding of the invasive margin might improve outcomes by facilitating more complete surgical resection beyond the traditional contrast enhancing margins. Diffusion tensor MRI (DTI) is an imaging technique which may be able to predict the site of tumour recurrence. DTI has previously been shown to identify regions, which have been confirmed with biopsies, to be areas of invasive tumours and are present before progression is seen with an MRI.\n\nThe primary aim of this study is to qualify an imaging biomarker that can be applied at initial presentation, that can accurately predict the site of where glioblastomas will progress after treatment and allow personalisation of both radiotherapy and surgical targets.', 'detailedDescription': 'This is a multicentre, prospective longitudinal observational cohort study in patients with high grade glioma, who have surgery planned to remove \\>90% of the tumour, and subsequent radical radiotherapy with concomitant tomozolomide. The purpose of this study is to establish a model using DTI that can accurately predict the site of where glioblastomas will progress after treatment. This study aims to validate the use of DTI as a biomarker across multiple centres to develop analysis methods that could be used in the future to personalise radiotherapy treatment volumes, and potentially surgical targets.\n\nPatients will be given a DTI-MRI both prior to the operation and prior to radiotherapy. Clinical MRIs will take place according to standard guidelines. Whilst the study is open patients will participate in the study until death. Once a total of 70 patients from the first 90 have shown true progression patients will participate in the study for a minimum of 6 months from the beginning of radiotherapy.\n\nThis study will be conducted in 6-10 NHS centres, where 120 patients will be recruited, patients who are withdrawn will be replaced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients aged 16 and over with newly diagnosed glioblastomas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have given written informed consent to participate\n* Assessed by a neuroscience MDT to have a high grade glioma on imaging, OR if in the opinion of the CI, with guidance from the local PI that all relevant and appropriate members of a multidisciplinary team agree a high grade glioma diagnosis;\n* Considered suitable for radical radiotherapy (60 Gy) with concomitant chemotherapy (Stupp Regime);\n* WHO PS 0 or 1 (see Appendix 3);\n* Age ≥16;\n* Patient suitable for tumour resection where the treating neurosurgeon feels that \\>90% of the enhancing tumour will be resected;\n\nExclusion Criteria:\n\n* Patients who are participating in trials involving investigational treatments\n* Patients who are unsuitable for a contrast-enhanced MRI will be excluded. Such clinical problems include, but are not limited to:\n* MR unsafe metallic implants;\n* Claustrophobia;\n* Allergy to gadolinium contrast agent;\n* History of severe renal impairment.\n* Patients unable to provide written informed consent\n* PET sub-study only: Pregnant women'}, 'identificationModule': {'nctId': 'NCT03294434', 'acronym': 'PRaM-GBM', 'briefTitle': 'Predicting Sites of Tumour Progression in the Invasive Margin of Glioblastomas (PRaM-GBM Study)', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Predicting Sites of Tumour Progression in the Invasive Margin of Glioblastomas (PRaM-GBM Study)', 'orgStudyIdInfo': {'id': 'PRaM-GBM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High Grade Glioma', 'description': 'Diffusion tensor Imaging (DTI-MRI) scan to be performed pre-operatively and pre-radiotherapy', 'interventionNames': ['Other: Diffusion tensor Imaging (DTI)']}], 'interventions': [{'name': 'Diffusion tensor Imaging (DTI)', 'type': 'OTHER', 'description': 'Diffusion tensor Imaging (DTI) is a technique sensitive to the ordered diffusion of water along white matter tracts and can detect subtle disruption. A diffusion tensor signature method was developed that splits the tensor information into isotropic and anisotropic diffusion components. This can differentiate regions of pure tumour from invaded white matter.', 'armGroupLabels': ['High Grade Glioma']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Stephen Price', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CCTU- Cancer Theme', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Cancer Research UK', 'class': 'OTHER'}, {'name': 'Experimental Cancer Medicine Centres', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'CCTU-Cancer Theme', 'investigatorFullName': 'CCTU- Cancer Theme', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}