Clinical trial · Interventional
68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High Risk Meningioma
Phase 1 Trial of 68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High-Risk Meningiomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): dose escalation trial, and the first 3 patients (who made up a cohort) were all accrued
Summary
Brief summary (as posted)
The is phase 1 trial of 68Ga-Dotatate PET/MRI guided radiation dose escalation for high-risk meningiomas (defined as recurrent or subtotal resection of Grade 2, and any Grade 3 meningioma). A modified toxicity probability interval schedule will be implemented with a Bayesian Optimal interval suite. It includes 4 dose cohort (66 Gy, 69 Gy, 72 Gy and 75 Gy). The initial study cohort will include 3 patients treated with 69 Gy in 30 daily fractions. The investigators will seek to determine the MTD of radiation therapy based DLTs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Meningioma | — | UNRESOLVED | — |
| Recurrent Meningioma | Meningioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ⁶⁸Ga-Dotatate PET and MRI Guided Radiation Therapy | Radiation | — | UNRESOLVED |
| 68Ga-Dotatate PET Imaging | Diagnostic Test | — | UNRESOLVED |
| EuroQol-5 Dimension (ED-5D) | Diagnostic Test | — | UNRESOLVED |
| Magnetic Resonance Imaging (MRI) | Diagnostic Test | — | UNRESOLVED |
| MD Anderson Symptom Inventory Bain Tumor form (MDASI-BT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Arm 1: Dose Level 1 - 66 Gy
- description
- Participants receive 68Ga-Dotatate PET and MRI guided external beam radiation therapy (EBRT) with intensity-modular radiation therapy (IMRT) or volumetric arc radiation therapy (VMAT). Two planning target volumes (PTV) will be required, including PTV and PTV-high. PTV\_High will be given a dose of 66 Gy in 30 once daily fractions. PTV will receive 60 Gy in 30 fractions concurrently.
- interventionNames
- Radiation: ⁶⁸Ga-Dotatate PET and MRI Guided Radiation Therapy
- Diagnostic Test: Magnetic Resonance Imaging (MRI)
- Diagnostic Test: 68Ga-Dotatate PET Imaging
- Other: MD Anderson Symptom Inventory Bain Tumor form (MDASI-BT)
- Diagnostic Test: EuroQol-5 Dimension (ED-5D)
- type
- EXPERIMENTAL
- label
- Arm 2: Dose Level 2 - 69 Gy
- description
- Participants receive 68Ga-Dotatate PET and MRI guided external beam radiation therapy (EBRT) with intensity-modular radiation therapy (IMRT) or volumetric arc radiation therapy (VMAT). Two planning target volumes (PTV) will be required, including PTV and PTV-high. PTV\_High will be given a dose of 69 Gy in 30 once daily fractions. PTV will receive 60 Gy in 30 fractions concurrently.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
1. Adult patients, age ≥ 18 years
2. Patients with RTOG Group III meningioma (high risk) defined as:
* Patients with newly diagnosed or a recurrent WHO grade 3 meningioma of any resection extent.
* or patients with a recurrent WHO grade 2 meningioma of any resection extent.
* or patient with a newly diagnosed sub-totally resected (residual nodular enhancement or PET enhancement on postoperative imaging, or Simpson grade IV or V excision) WHO grade 2 meningioma.
3. In the setting of newly diagnosed meningioma, the histologic diagnosis must be within 6 months of registration.
4. In the setting of a recurrent meningioma, there are no such time constraints. However, additional resection or biopsy is encouraged for patients with recurrence but is not requisite. If further biopsy or resection is performed at recurrence, it must be within 6 months of registration.
5. Karnofsky Performance Status 60-100
6. MRI brain and ⁶⁸Ga-Dotatate PET must be performed within 6 weeks prior to registration.
7. For woman of childbearing potential:
* A negative serum pregnancy test is required within 14 days prior to registration.
* The patient must agree to practice adequate contraception from the time of the negative serum pregnancy test throughout the entire course of EBRT.
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in this study:
1. Extracranial meningioma
2. Prior radiation therapy to the scalp, cranium, brain, or skull base
3. Prior malignancy (except for non-melanomatous skin cancer), unless disease free for at least 3 years
4. Pregnancy or lactation
5. Treatment with another investigational drug or other intervention at time of registration
6. Inability to receive gadolinium or undergo MRI brain or ⁶⁸Ga-Dotatate PET imaging.
7. Serious medical or psychiatric illness likely to interfere with participation in this clinical trial.
8. Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema)
9. Uncontrolled seizureReferences
Publications (0)
Data not yet available