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MeDex: No Perioperative Dexamethasone in Brain Metastases
RECRUITINGN/ASponsored by University of Louisville
Actively Recruiting
PhaseN/A
SponsorUniversity of Louisville
Started2025-12-03
Est. completion2027-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07044557
Summary
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: 1. New brain tumor(s) on imaging 2. Visceral mass(es) suspicious or confirmed for neoplasm 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 3. No contraindications for craniotomy 4. Age ≥ 18 years 5. ECOG performance status ≤ 2 (i.e., ambulatory \> 50% of waking hours) 6. Midline shift on MRI ≤ 10 mm 7. Craniotomy planned to resect \>75% of the enhancing mass (surgeon's judgment) Exclusion Criteria: 1. Presence of BMs not eligible for resection that are each \> 2 cm in any one dimension 2. \>4 BMs not eligible for resection that are each 2 cm in any one dimension 3. Treatment with laser interstitial thermal therapy (LITT) 4. High concern for primary CNS lymphoma 5. Diagnosis of small cell lung carcinoma 6. Any receipt of Dex 7. Steroid use in the past month 8. A condition that requires steroids 9. Stage 4 chronic kidney disease (GFR\<30) 10. Pregnant or breastfeeding
Conditions2
Brain MetastasesCancer
Locations1 site
University of Louisville Hospital
Louisville, Kentucky, 40202
Mechelle Kaufman, BSN502-852-1513
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Actively Recruiting
PhaseN/A
SponsorUniversity of Louisville
Started2025-12-03
Est. completion2027-10
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07044557