Brain MetastasesNCT07044557
MeDex: No Perioperative Dexamethasone in Brain Metastases
A study testing Withholding perioperative Dexamethasone in people with Brain Metastases, run by University of Louisville at 1 site in United States.
Trial summary
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Withholding perioperative Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New brain tumor(s) on imaging
- Visceral mass(es) suspicious or confirmed for neoplasm
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Steroid use in the past month
- A condition that requires steroids
- Stage 4 chronic kidney disease (GFR<30)
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
Mechelle Kaufman, BSN, 502-852-1513
Akshitkumar Mistry, MD
About this study
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
Read the detailed description
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.
- Conditions
- Brain Metastases
- Being tested
- Withholding perioperative Dexamethasone
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withholding perioperative DexamethasoneOther
Patients will not receive perioperative Dex before, during, and up to 3 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Withholding perioperative dexamethasone | Experimental | 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. Receives: Other: Withholding perioperative Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexamethasone Rescue Need
Initiation of dexamethasone after enrollment up to 3 weeks after surgery.
Measured: 4 weeks post operative (+-) 2 weeks
Secondary outcomes (1)
Immunosuppression Assessment
Presence of absence of lymphopenia prior to adjuvant cancer therapy.
Measured: 4 weeks post operative (+-) 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Aug 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akshitkumar MIstry, University of Louisville
- Investigators
- Akshitkumar Mistry, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044557
- Sponsor's protocol ID
- 25.0244
- Status last verified
- May 2026
- First submitted
- 23 Jun 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MeDex: No Perioperative Dexamethasone in Brain Metastases
- ClinicalTrials.gov ID
- NCT07044557
- Acronym / sponsor ID
- 25.0244
- Conditions
- Brain Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perioperative treatment of newly diagnosed cancer patients with brain metastasis without dexamethasone (Dex).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Withholding perioperative dexamethasone | Experimental | Other: Withholding perioperative DexamethasoneThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- New brain tumor(s) on imaging
- Visceral mass(es) suspicious or confirmed for neoplasm
- No contraindications for craniotomy
- Age ≥ 18 years
- ECOG performance status ≤ 2 (i.e., ambulatory > 50% of waking hours)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withholding perioperative DexamethasonePatients will not receive perioperative Dex before, during, and up to 3 weeks after surgery. | Other | Withholding perioperative dexamethasone |
Primary outcome
Dexamethasone Rescue Need
Time frame: 4 weeks post operative (+-) 2 weeks
Initiation of dexamethasone after enrollment up to 3 weeks after surgery.
1 secondary outcome
Immunosuppression Assessment
Time frame: 4 weeks post operative (+-) 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akshitkumar Mistry, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withholding perioperative Dexamethasone in people with Brain Metastases, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A Mistry, MD (502-276-5030, akshitkumar.mistry@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexamethasone Rescue Need (time frame: 4 weeks post operative (+-) 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.