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68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High Risk Meningioma

NCT07353229 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-23

No results posted yet for this study

Summary

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

  • High Risk Meningioma
  • Recurrent Meningioma

Interventions

RADIATION

⁶⁸Ga-Dotatate PET and MRI Guided Radiation Therapy

The radiation dose levels will be 66, 69, 72, and 75 Gy in 30 daily fractions based on the design.

DIAGNOSTIC_TEST

Magnetic Resonance Imaging (MRI)

MRI brain with and without contrast must be performed within 6 weeks prior to registration. MRI brain will be performed at 3-, 6-, 9-, 12-, 18-, and 24 months. If surgery is performed, MRI must be performed after surgery.

DIAGNOSTIC_TEST

68Ga-Dotatate PET Imaging

⁶⁸(GA)Dotatate PET must be performed within 6 weeks prior to registration. 12 months after radiation treatment +/- 1 month patients are required to get Ga-Dotatate PET.

OTHER

MD Anderson Symptom Inventory Bain Tumor form (MDASI-BT)

Every 3 m ± 2 weeks, starting 3 m ± 2 weeks post radiation treatment. MRI at the 9 month post radiation visit is only to be completed if per physician discretion it is clinically indicated, except for patients with grade 3 meningioma, the 9 month MRI is required. At month 18 ± 4 weeks, and month 24 ± 4 weeks after radiation treatment.

DIAGNOSTIC_TEST

EuroQol-5 Dimension (ED-5D)

Every 3 m ± 2 weeks, starting 3 m ± 2 weeks post radiation treatment. MRI at the 9 month post radiation visit is only to be completed if per physician discretion it is clinically indicated, except for patients with grade 3 meningioma, the 9 month MRI is required. At month 18 ± 4 weeks, and month 24 ± 4 weeks after radiation treatment.

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-05
Primary Completion
2026-09-30
Completion
2028-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07353229 on ClinicalTrials.gov