Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT07044557
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07044557
Study Brief:
Protocol Section:
NCT07044557