Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-28 @ 8:17 AM
Study NCT ID:
NCT04542603
Status:
WITHDRAWN
Last Update Posted:
2024-04-25
First Post:
2020-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C475519', 'term': "2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No recruitment/enrollment and funding expired.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure neuroinflammation by calculating the concentration and regional distribution of activated brain microglia/macrophages using the PET ligand [F-18]DPA-714.', 'timeFrame': 'Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)'}], 'secondaryOutcomes': [{'measure': 'Correlate cognitive impairment before and after beginning cancer therapy with the concentration and regional brain distribution of pathologic amyloid deposition measured with the PET tracer [C-11]PiB prior to beginning therapy.', 'timeFrame': 'Pre-study visit through 3-6 cycles of chemotherapy (each cycle is typically 2 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'This clinical study will use the small molecule translocator protein (TSPO) ligand, 18F-labeled DPA- 714, to visualize and quantify neuroinflammation in treatment naivete women with stage 1-4 newly diagnosed ovarian cancer (without brain metastases) prior to starting neoadjuvant chemotherapy treatment (baseline) and within a month of completing first 6 cycles of cytotoxic chemotherapy treatment (follow-up). In addition, we will use the well-characterized small molecule PET(Positron Emission Tomography) tracer, 11C-labeled Pittsburgh compound B (PiB) to visualize and quantify the regional brain distribution of pathological amyloid deposition at baseline only. The brain amyloid PET and MRI data acquired through this study will be correlated with cognitive test data, clinical data, genetic testing, and biospecimens collected in this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 50 years of age or older\n2. Female gender\n3. Newly diagnosed treatment naïve women with stage III/IV epithelial ovarian cancer (without known brain metastases).\n4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.\n5. English is primary language\n6. Planned neoadjuvant chemotherapy with platinum and taxane drugs\n\nExclusion Criteria:\n\n1. Contraindication to MRI\n2. Pregnancy\n3. Lactation\n4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition\n5. Chronic infectious disease (e.g. HIV, HCV)\n6. Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease\n7. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation\n8. Blood or blood clotting disorder\n9. Cancer that has metastasized to the brain\n10. Positive urine hCG test day of procedure or a serum hCG test within 48 hours prior to the administration of \\[18F\\]DPA-714 and \\[11C\\]PiB.\n11. Currently enrolled in a clinical trial utilizing experimental therapies.\n12. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.\n13. Prior brain tumor or other neurological condition known to affect cognition\n14. A diagnosis of dementia unrelated to cancer or an adjusted MMSE score \\< 24'}, 'identificationModule': {'nctId': 'NCT04542603', 'briefTitle': 'Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer', 'orgStudyIdInfo': {'id': 'R20-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment naivete women with stage 1-4 newly diagnosed ovarian', 'interventionNames': ['Drug: [11C]PiB and 18F-labeled DPA-714 PET scan']}], 'interventions': [{'name': '[11C]PiB and 18F-labeled DPA-714 PET scan', 'type': 'DRUG', 'description': 'One PET with \\[11C\\]PiB and One PET with \\[18F\\]DPA-714 before chemotherapy treatment begins. One more PET with \\[18F\\]DPA-714 after completion of 3-6 cycles of chemotherapy.', 'armGroupLabels': ['treatment naivete women with stage 1-4 newly diagnosed ovarian']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jonathan McConathy, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics Affiliation: University of Alabama at Birmingham Collaborators:', 'investigatorFullName': 'Jonathan E McConathy', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}