Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-29 @ 12:16 PM
Study NCT ID:
NCT07044557
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MeDex: No Perioperative Dexamethasone in Brain Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone. We will conduct a single-arm trial, assessing the safety and efficacy of brain metastasis resection without perioperative Dex. We will assess efficacy by noting presence of absence of lymphopenia. The participants will be followed until initiation of postoperative adjuvant cancer therapy for collection of primary and secondary endpoints.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dexamethasone Rescue Need', 'timeFrame': '4 weeks post operative (+-) 2 weeks', 'description': 'Initiation of dexamethasone after enrollment up to 3 weeks after surgery.'}], 'secondaryOutcomes': [{'measure': 'Immunosuppression Assessment', 'timeFrame': '4 weeks post operative (+-) 2 weeks', 'description': 'Presence of absence of lymphopenia prior to adjuvant cancer therapy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Metastases']}, 'descriptionModule': {'briefSummary': 'Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).', 'detailedDescription': 'This is a single-arm trial, assessing the safety and efficacy of brain metastasis resection without perioperative Dex in a maximum of 35 patients screened and enrolled in our emergency room and clinics. Investigators will assess efficacy by noting presence of absence of lymphopenia. The patients will be followed until initiation of postoperative adjuvant cancer therapy for collection of primary and secondary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. New brain tumor(s) on imaging\n2. Visceral mass(es) suspicious or confirmed for neoplasm\n\n a. Patients with lung mass suspicious for primary lung cancer and no prior diagnosis must undergo biopsy of the lung mass prior to resection of brain metastasis(es) to exclude histology (i.e., small cell lung carcinoma) that would not benefit from resection\n3. No contraindications for craniotomy\n4. Age ≥ 18 years\n5. ECOG performance status ≤ 2 (i.e., ambulatory \\> 50% of waking hours)\n6. Midline shift on MRI ≤ 10 mm\n7. Craniotomy planned to resect \\>75% of the enhancing mass (surgeon's judgment)\n\nExclusion Criteria:\n\n1. Presence of BMs not eligible for resection that are each \\> 2 cm in any one dimension\n2. \\>4 BMs not eligible for resection that are each 2 cm in any one dimension\n3. Treatment with laser interstitial thermal therapy (LITT)\n4. High concern for primary CNS lymphoma\n5. Diagnosis of small cell lung carcinoma\n6. Any receipt of Dex\n7. Steroid use in the past month\n8. A condition that requires steroids\n9. Stage 4 chronic kidney disease (GFR\\<30)\n10. Pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT07044557', 'briefTitle': 'MeDex: No Perioperative Dexamethasone in Brain Metastases', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'MeDex: No Perioperative Dexamethasone in Brain Metastases', 'orgStudyIdInfo': {'id': '25.0244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Withholding perioperative dexamethasone', 'description': 'The safety and feasibility of withholding perioperative dexamethasone (Dex) in newly diagnosed cancer patients undergoing resection of brain metastases (BMs). The primary question is not comparative efficacy, but rather whether it is safe to forgo Dex in this patient population.', 'interventionNames': ['Other: Withholding perioperative Dexamethasone']}], 'interventions': [{'name': 'Withholding perioperative Dexamethasone', 'type': 'OTHER', 'description': 'Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.', 'armGroupLabels': ['Withholding perioperative dexamethasone']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'A Mistry, MD', 'role': 'CONTACT', 'email': 'akshitkumar.mistry@louisville.edu', 'phone': '502-276-5030'}, {'name': 'M Kaufman, BSN', 'role': 'CONTACT', 'email': 'mdkauf02@louisville.edu', 'phone': '502-852-1513'}], 'overallOfficials': [{'name': 'Akshitkumar Mistry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Assistant Professor', 'investigatorFullName': 'Akshitkumar MIstry', 'investigatorAffiliation': 'University of Louisville'}}}}