Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT04440358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2020-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Adverse Events', 'timeFrame': 'Through study completion, an average of 12 months', 'description': 'All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria'}, {'measure': 'Contrast intensity on MR imaging', 'timeFrame': 'Immediately after Exablate BBBD procedure', 'description': 'BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exablate', 'Focused Ultrasound', 'Carboplatin'], 'conditions': ['Recurrent Glioblastoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.', 'detailedDescription': 'This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system. Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be between 18-80 years old\n* Histologically confirmed glioblastoma\n* Planned for Carboplatin monotherapy\n* Be willing and able to provided written informed consent/assent\n* Tumor progression after first line therapy\n* Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy\n* Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception\n* Able to communicate verbally\n\nExclusion Criteria:\n\n* Acute intracranial hemorrhage\n* Ferrous metallic implanted objects in the skull or brain\n* Prior toxicity with carboplatin chemotherapy\n* Women who are pregnant or breastfeeding\n* Cerebellar spinal cord or brain stem tumor\n* Known active Hepatitis B or Hepatitis C or HIV\n* Significant depression not adequately controlled\n* Cardiac disease or unstable hemodynamics\n* Severe hypertension\n* History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage\n* Active drug or alcohol use disorder\n* Known sensitivity to gadolinium-based contrast agents\n* Known sensitivity or contraindications to ultrasound contrast agent or perflutren\n* Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices\n* Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication\n* Severely impaired renal function\n* Right to left or bi-directional cardiac shunt\n* Cranial or systemic infection requiring antibiotics\n* Known additional malignancy that is progression or require active treatment'}, 'identificationModule': {'nctId': 'NCT04440358', 'briefTitle': 'Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM', 'organization': {'class': 'INDUSTRY', 'fullName': 'InSightec'}, 'officialTitle': 'Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy', 'orgStudyIdInfo': {'id': 'BT009 [OUS]'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exablate BBBD with carboplatin', 'description': "Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to carboplatin administration.", 'interventionNames': ['Device: Exablate BBBD', 'Drug: Carboplatin']}], 'interventions': [{'name': 'Exablate BBBD', 'type': 'DEVICE', 'otherNames': ['Exablate Neuro'], 'description': 'BBB opening via Exablate Neuro Type 2 system to deliver carboplatin', 'armGroupLabels': ['Exablate BBBD with carboplatin']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain', 'armGroupLabels': ['Exablate BBBD with carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS Neurologico Carlo Besta', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InSightec', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}