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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07469735
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or molecularly confirmed WHO 2021 grade 2 or 3 IDH1/2-mutant diffuse glioma with recurrent or residual disease
2. At least one measurable non-enhancing lesion (≥1 cm × ≥1 cm) on postoperative T2/FLAIR MRI
3. Eligible for Vorasidenib treatment
4. Age ≥18 years
5. Karnofsky Performance Status (KPS) score ≥80
6. Adequate hematologic function
7. Adequate renal function
8. Adequate hepatic function
9. Ability to provide written informed consent
Exclusion Criteria:
1. Prior treatment with radiotherapy, chemotherapy, or IDH inhibitors
2. Known contraindications to Vorasidenib
3. Contraindications to PET/CT imaging
4. Uncontrolled hyperglycemia
5. Pregnancy or breastfeeding
6. Inability to undergo repeated intravenous injections
7. Known hypersensitivity to imaging agents or study-related medications
8. Use of strong CYP1A2 inhibitors or CYP2C19 or CYP3A substrates with narrow therapeutic index
9. Any serious comorbid condition that may interfere with study participation or safety
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07469735
Study Brief:
Protocol Section:
NCT07469735