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Recruiting

NCT Number: NCT07044557

MeDex: No Perioperative Dexamethasone in Brain Metastases

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Akshitkumar Mistry, MD

PRINCIPAL_INVESTIGATOR

Mechelle Kaufman, BSN

CONTACT

502-852-1513

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New brain tumor(s) on imaging
  • 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

  • No contraindications for craniotomy
  • Age ≥ 18 years
  • ECOG performance status ≤ 2 (i.e., ambulatory > 50% of waking hours)
  • Midline shift on MRI ≤ 10 mm
  • Craniotomy planned to resect >75% of the enhancing mass (surgeon's judgment)

Exclusion criteria

  • Presence of BMs not eligible for resection that are each > 2 cm in any one dimension
  • >4 BMs not eligible for resection that are each 2 cm in any one dimension
  • Treatment with laser interstitial thermal therapy (LITT)
  • High concern for primary CNS lymphoma
  • Diagnosis of small cell lung carcinoma
  • Any receipt of Dex
  • Steroid use in the past month
  • A condition that requires steroids
  • Stage 4 chronic kidney disease (GFR<30)
  • Pregnant or breastfeeding

Treatment and study plan

Withholding perioperative Dexamethasone

Other

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

Primary outcomes

  1. Dexamethasone Rescue Need

    Time frame: 4 weeks post operative (+-) 2 weeks

    Initiation of dexamethasone after enrollment up to 3 weeks after surgery.

Secondary outcomes

  1. Immunosuppression Assessment

    Time frame: 4 weeks post operative (+-) 2 weeks

    Presence of absence of lymphopenia prior to adjuvant cancer therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

A Mistry, MD

CONTACT

[email protected]

502-276-5030

M Kaufman, BSN

CONTACT

[email protected]

502-852-1513

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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