Recruiting

Perioperative Treatment

Sponsor:

University of Louisville

Code:

NCT07044557

Conditions

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Withholding perioperative Dexamethasone

Study Details

Brief summary:

Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).

Conditions

Brain Metastases

Study ID

NCT07044557

Start date

Aug 1, 2026

Status verified date

May, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Withholding perioperative dexamethasone

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.

Interventions

Withholding perioperative Dexamethasone

Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.

Primary outcome measure

  • Dexamethasone Rescue Need [ Time Frame: 4 weeks post operative (+-) 2 weeks ]

Central Contacts and Locations

Locations

University of Louisville Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Mechelle Kaufman, BSN

502-852-1513

Principal Investigator:

Akshitkumar Mistry, MD

More Information

Sponsor

University of Louisville

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-05-29.