Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-27 @ 7:34 AM
Study NCT ID:
NCT01961934
Status:
WITHDRAWN
Last Update Posted:
2016-09-28
First Post:
2013-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615233', 'term': 'Carbon-11'}, {'id': 'C438206', 'term': 'carbon-11 acetate'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Awaiting funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2013-10-10', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biopsy Correlation', 'timeFrame': '3 weeks from AC PET Imaging', 'description': 'AC PET imaging results will be correlated with tissue biopsy results'}], 'secondaryOutcomes': [{'measure': 'SUV (Standardized Uptake Value)', 'timeFrame': 'Day 1 - Assess at time of PET imaging', 'description': 'Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest. Comparison of the lesional activity to normal contralateral tracer activity will also be measured.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glioblastoma', 'high grade brain tumors', 'recurrent', 'pseudo-progression', 'radionecrosis', 'carbon acetate', 'C11 aceate', 'PET', 'positron emission tomography'], 'conditions': ['Gliomas']}, 'descriptionModule': {'briefSummary': 'This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly identify recurrent tumor versus post treatment effects (radionecrosis) in patients with previously treated high grade brain gliomas.', 'detailedDescription': 'The study is designed to investigate the effectiveness of Carbon Acetate PET/CT (AC PET)in terms of its ability to distinguish between radionecrosis/pseudo-progression and viable tumor in patients previously treated with surgery and radiation for high grade glioma brain tumors.\n\nEligible patients with biopsy proven high grade gliomas (WHO grades 3 and 4) status-post prior cranial irradiation for this tumor; age 18 to 70; ECOG/Zubrod of 0-2, no other contraindications to trial entry, and a post-irradiation cranial MRI or CT demonstrating an enhancing lesion of uncertain etiology (not biopsied) will be treated with at least two weeks of steroidal therapy.\n\nResponders to steroidal therapy will be classified as either pseudo-progression (if asymptomatic) or radionecrosis (if symptomatic). Non-responders (those who do not respond clinically, radiographically, or both) will be referred for an FDG PET/CT and initial AC PET/CT within 3 weeks, and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment (in the same operative setting) within 3 weeks of AC PET/CT.\n\nSpecific Goals/Questions:\n\n1. What is the yield (sensitivity, accuracy, positive and negative predictive value) of state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population?\n2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET) and with that of MRI?\n3. Evaluate the optimal timing for post injection imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 18-70\n* Pathologically confirmed World Health Organization (WHO) grade 3 or 4 glioma\n* ECOG/Zubrod 0-2\n* Prior external beam radiotherapy to 59.4-60 Gray by 1.8-2 Gy fractions\n* Post-radiotherapy contrast-enhanced cranial MRI obtained at least 6 weeks after the completion of external beam radiotherapy shows enhancing anomaly (recurrent/progressive tumor versus pseudo-progression versus radionecrosis)\n* Patient completed at least a two week course of palliative steroid therapy for this enhancing anomaly\n* No prior designated therapy other than steroids for presumed radionecrosis or recurrent tumor\n* Patient with no clinical and/or radiological response to steroid therapy\n* Patient eligible for stereotactic brain biopsy\n* Patient eligible for focal laser therapy\n\nExclusion Criteria:\n\n* Patients under the age of 18 years\n* Claustrophobic patients'}, 'identificationModule': {'nctId': 'NCT01961934', 'briefTitle': 'C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression', 'organization': {'class': 'OTHER', 'fullName': 'Phoenix Molecular Imaging'}, 'officialTitle': 'Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression', 'orgStudyIdInfo': {'id': 'AMIC-AC-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Acetate C11 PET/CT Imaging', 'interventionNames': ['Drug: Sodium Acetate C11 PET/CT Imaging']}], 'interventions': [{'name': 'Sodium Acetate C11 PET/CT Imaging', 'type': 'DRUG', 'otherNames': ['Carbon 11 Acetate', 'C11 Acetate', 'AC-PET', 'PET Imaging with Acetate C11'], 'armGroupLabels': ['Sodium Acetate C11 PET/CT Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85040', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Molecular Imaging', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Fabio Almeida, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Director, Phoenix Molecular Imaging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phoenix Molecular Imaging', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director/PI', 'investigatorFullName': 'Fabio Almeida MD', 'investigatorAffiliation': 'Phoenix Molecular Imaging'}}}}