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

NCT07353229 | Suspended Phase 1

• 2 other identifiers: iRIS ID-2023-2983JT 38404
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

High-Risk Meningiomas; subtotal resection of Grade 2 meningioma; subtotal resection of Grade 3 meningioma; recurrent meningioma; 68Ga-Dotatate PET; MRI Guided Radiation; BOIN; maximum tolerated dose

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of 68Ga-Dotatate PET/MRI guided radiation dose escalation

  To establish MTD utilizing DLT rates (DLT will be defined as radiation treatment related G3 or higher neurological toxicity from beginning of radiation till 30 days after finishing radiation treatment).

  30 days post-treatment

Secondary Outcomes (8)

• Late Neurological Toxicities of Radiation Treatment

  up to 2 year post-treatment

• Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire

  Baseline

• Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire

  3 months (+/- 2 weeks)

• Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire

  6 months (+/- 2 weeks)

• Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire

  9 months (+/- 2 weeks)

Other Outcomes (9)

• Local Control at 1 year from Registration

  at 1 year from Registration

• Local Control at 2 years from Registration

  at 2 years from Registration

• Local Control at 3 years from Registration

  at 3 years from Registration

Study Arms (5)

Arm 1: Dose Level 1 - 66 Gy

EXPERIMENTAL

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.

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)

Arm 2: Dose Level 2 - 69 Gy

EXPERIMENTAL

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.

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)

Arm 3: Dose Level 3 - 72 Gy

EXPERIMENTAL

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 72 Gy in 30 once daily fractions. PTV will receive 60 Gy in 30 fractions concurrently.

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)

Arm 4: Dose Level 4 - 75 Gy

EXPERIMENTAL

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 75 Gy in 30 once daily fractions. PTV will receive 60 Gy in 30 fractions concurrently.

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)

MTD Expansion Cohort

EXPERIMENTAL

Once the maximum tolerated dose (MTD) is established, an additional 12 patients will be enrolled at that dose level. Participants will receive 68Ga-Dotatate PET imaging and MRI-guided external beam radiation therapy (EBRT), delivered using either intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). Two planning target volumes (PTVs) will be defined: PTV and PTV-High. PTV-High will receive the MTD (in Gy) delivered in 30 once-daily fractions. PTV will concurrently receive 60 Gy in 30 fractions.

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)

Interventions

⁶⁸Ga-Dotatate PET and MRI Guided Radiation Therapy RADIATION

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

Arm 1: Dose Level 1 - 66 Gy; Arm 2: Dose Level 2 - 69 Gy; Arm 3: Dose Level 3 - 72 Gy; Arm 4: Dose Level 4 - 75 Gy; MTD Expansion Cohort

Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

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.

Also known as: MRI

Arm 1: Dose Level 1 - 66 Gy; Arm 2: Dose Level 2 - 69 Gy; Arm 3: Dose Level 3 - 72 Gy; Arm 4: Dose Level 4 - 75 Gy; MTD Expansion Cohort

68Ga-Dotatate PET Imaging DIAGNOSTIC_TEST

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.

Also known as: GaTate PET, Gallium-68 DOTATATE Scan, DOTA-TATE imaging

Arm 1: Dose Level 1 - 66 Gy; Arm 2: Dose Level 2 - 69 Gy; Arm 3: Dose Level 3 - 72 Gy; Arm 4: Dose Level 4 - 75 Gy; MTD Expansion Cohort

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

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.

Also known as: Survey

Arm 1: Dose Level 1 - 66 Gy; Arm 2: Dose Level 2 - 69 Gy; Arm 3: Dose Level 3 - 72 Gy; Arm 4: Dose Level 4 - 75 Gy; MTD Expansion Cohort

EuroQol-5 Dimension (ED-5D) DIAGNOSTIC_TEST

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.

Also known as: Survey

Arm 1: Dose Level 1 - 66 Gy; Arm 2: Dose Level 2 - 69 Gy; Arm 3: Dose Level 3 - 72 Gy; Arm 4: Dose Level 4 - 75 Gy; MTD Expansion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, age ≥ 18 years
• 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.
• In the setting of newly diagnosed meningioma, the histologic diagnosis must be within 6 months of registration.
• 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.
• Karnofsky Performance Status 60-100
• MRI brain and ⁶⁸Ga-Dotatate PET must be performed within 6 weeks prior to registration.
• 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Extracranial meningioma
• Prior radiation therapy to the scalp, cranium, brain, or skull base
• Prior malignancy (except for non-melanomatous skin cancer), unless disease free for at least 3 years
• Pregnancy or lactation
• Treatment with another investigational drug or other intervention at time of registration
• Inability to receive gadolinium or undergo MRI brain or ⁶⁸Ga-Dotatate PET imaging.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical trial.
• Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema)
• Uncontrolled seizure

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Meningioma

Interventions

Magnetic Resonance Imaging; Surveys and Questionnaires; Fertility

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Wenyin Shi, MD, PhD

  Wenyin.Shi@jefferson.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)