High Risk MeningiomaPhase 1NCT07353229
68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High Risk Meningioma
A Phase 1 study testing ⁶⁸Ga-Dotatate PET and MRI Guided Radiation Therapy, Magnetic Resonance Imaging (MRI) and 68Ga-Dotatate PET Imaging in people with High Risk Meningioma and Recurrent Meningioma, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Meningioma, Recurrent Meningioma
- What is being tested?
- ⁶⁸Ga-Dotatate PET and MRI Guided Radiation Therapy, Magnetic Resonance Imaging (MRI) and 68Ga-Dotatate PET Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to Sep 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Phase 1 Trial of 68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High-Risk Meningiomas
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.
Read the detailed description
Patient will be enrolled, and dose selected per modified toxicity probability interval utilizing a Bayesian Optimal interval suite to maximize the probability that selecting the MTD dose that has a target DLT rate under 30% while optimizing patient safety over the 3+3 trial design 15. For our initial cohort the investigators will seek to treat 3 patients at 69 Gy in 30 daily fractions, Monday-Friday for 6 weeks of treatment utilizing MRI/PET target delineation with IMRT/VMAT. Patients will be followed weekly for on-treatment visits and 30 days from end of radiation to evaluate for DLTs classified as grade 3+ toxicity by NCI-CTCAE v5.0. Subsequent dosing will be determined by DLTs experienced utilizing a modified toxicity probability interval design. If the stopping rule is met, the trial will discontinue enrollment and select the MTD. If the stopping rule is not met, the DLT rate will be computed at the current treated dose. DLT rate is calculated by the total number of patients experiencing DLT at the current dose divided by total number of evaluable patients at the current dose. With a DLT rate of less than or equal to 0.236 dose will be escalated by 3 Gy, DLT rate greater than 0.359 will de-escalate the dose by 3 Gy. A rate between 0.236 and 0.359 will retain the current dose. An additional 3 patients will then be enrolled at specified dose depending on DLT rate. Patients will be treated and followed to assess for acute DLTs. The process will be repeated with enrollment discontinued if stopping rule met or additional patient will be enrolled at a dose from 66 - 75 Gy in 30 fractions based on new DLT rate. Enrollment utilizing DLT rate will be discontinued once stopping rule met or 12 patients are enrolled and an MTD will be established. Once the MTD has been established, an additional 12 patients at the MTD will then be enrolled.
Following radiation treatment (with once weekly on-treatment visits) and evaluation 1 month following completion for radiation, patients will be evaluated 3-, 6-, 9, 12-, 18-, and 24-months post-treatment utilizing NCI-CTCAEv5.0, symptom burden and QOL questionnaires, and MRI imaging to evaluate for safety, toxicity, and treatment efficacy.
The study population will include any adult patients, with high-risk meningioma as defined by RTOG definition (Grade 2 meningioma with subtotal resection or recurrence, and any Grade 3 meningioma).
It is believed dose escalation with IMRT/VMAT therapy is feasible and well tolerated with improved target delineation utilizing both MRI and PET fusion with an acceptable toxicity profile.
- Conditions
- High Risk Meningioma, Recurrent Meningioma
- Being tested
- ⁶⁸Ga-Dotatate PET and MRI Guided Radiation Therapy, Magnetic Resonance Imaging (MRI), 68Ga-Dotatate PET Imaging, MD Anderson Symptom Inventory Bain Tumor form (MDASI-BT), EuroQol-5 Dimension (ED-5D)
- 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
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
⁶⁸Ga-Dotatate PET and MRI Guided Radiation TherapyRadiation
The radiation dose levels will be 66, 69, 72, and 75 Gy in 30 daily fractions based on the design.
Magnetic Resonance Imaging (MRI)Diagnostic test
Also called 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.
68Ga-Dotatate PET ImagingDiagnostic test
Also called GaTate PET, Gallium-68 DOTATATE Scan, DOTA-TATE 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.
MD Anderson Symptom Inventory Bain Tumor form (MDASI-BT)Other
Also called Survey
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.
EuroQol-5 Dimension (ED-5D)Diagnostic test
Also called Survey
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days post-treatment
Secondary outcomes (8)
Late Neurological Toxicities of Radiation Treatment
Number of participants experiencing radiation treatment related G3 or higher neurological toxicity from beginning of radiation till 30 days after finishing radiation treatment.
Measured: up to 2 year post-treatment
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Patient reported symptom severity and interference will be assessed using the MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire. It consists of 23 symptoms rated on an 11-point scale (0 to 10) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours. The interference items also are measured on 0-10 scales.
Measured: Baseline
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Patient reported symptom severity and interference will be assessed using the MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire. It consists of 23 symptoms rated on an 11-point scale (0 to 10) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours. The interference items also are measured on 0-10 scales.
Measured: 3 months (+/- 2 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Patient reported symptom severity and interference will be assessed using the MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire. It consists of 23 symptoms rated on an 11-point scale (0 to 10) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours. The interference items also are measured on 0-10 scales.
Measured: 6 months (+/- 2 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Patient reported symptom severity and interference will be assessed using the MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire. It consists of 23 symptoms rated on an 11-point scale (0 to 10) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours. The interference items also are measured on 0-10 scales.
Measured: 9 months (+/- 2 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Patient reported symptom severity and interference will be assessed using the MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire. It consists of 23 symptoms rated on an 11-point scale (0 to 10) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours. The interference items also are measured on 0-10 scales.
Measured: 12 months (+/- 2 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Patient reported symptom severity and interference will be assessed using the MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire. It consists of 23 symptoms rated on an 11-point scale (0 to 10) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours. The interference items also are measured on 0-10 scales.
Measured: 18 months (+/- 4 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Patient reported symptom severity and interference will be assessed using the MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire. It consists of 23 symptoms rated on an 11-point scale (0 to 10) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours. The interference items also are measured on 0-10 scales.
Measured: 24 months (+/- 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start5 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Why it stopped: dose escalation trial, and the first 3 patients (who made up a cohort) were all accrued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk MeningiomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenyin Shi, MD, PhD, Principal investigator, Wenyin.Shi@jefferson.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353229
- Sponsor's protocol ID
- iRIS ID-2023-2983
- Other IDs
- JT 38404
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Trial of 68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High-Risk Meningiomas
- ClinicalTrials.gov ID
- NCT07353229
- Acronym / sponsor ID
- iRIS ID-2023-2983
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: dose escalation trial, and the first 3 patients (who made up a cohort) were all accrued
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patient will be enrolled, and dose selected per modified toxicity probability interval utilizing a Bayesian Optimal interval suite to maximize the probability that selecting the MTD dose that has a target DLT rate under 30% while optimizing patient safety over the 3+3 trial design 15. For our initial cohort the investigators will seek to treat 3 patients at 69 Gy in 30 daily fractions, Monday-Friday for 6 weeks of treatment utilizing MRI/PET target delineation with IMRT/VMAT. Patients will be followed weekly for on-treatment visits and 30 days from end of radiation to evaluate for DLTs classified as grade 3+ toxicity by NCI-CTCAE v5.0. Subsequent dosing will be determined by DLTs experienced utilizing a modified toxicity probability interval design. If the stopping rule is met, the trial will discontinue enrollment and select the MTD. If the stopping rule is not met, the DLT rate will be computed at the current treated dose. DLT rate is calculated by the total number of patients experiencing DLT at the current dose divided by total number of evaluable patients at the current dose. With a DLT rate of less than or equal to 0.236 dose will be escalated by 3 Gy, DLT rate greater than 0.359 will de-escalate the dose by 3 Gy. A rate between 0.236 and 0.359 will retain the current dose. An additional 3 patients will then be enrolled at specified dose depending on DLT rate. Patients will be treated and followed to assess for acute DLTs. The process will be repeated with enrollment discontinued if stopping rule met or additional patient will be enrolled at a dose from 66 - 75 Gy in 30 fractions based on new DLT rate. Enrollment utilizing DLT rate will be discontinued once stopping rule met or 12 patients are enrolled and an MTD will be established. Once the MTD has been established, an additional 12 patients at the MTD will then be enrolled.
Following radiation treatment (with once weekly on-treatment visits) and evaluation 1 month following completion for radiation, patients will be evaluated 3-, 6-, 9, 12-, 18-, and 24-months post-treatment utilizing NCI-CTCAEv5.0, symptom burden and QOL questionnaires, and MRI imaging to evaluate for safety, toxicity, and treatment efficacy.
The study population will include any adult patients, with high-risk meningioma as defined by RTOG definition (Grade 2 meningioma with subtotal resection or recurrence, and any Grade 3 meningioma).
It is believed dose escalation with IMRT/VMAT therapy is feasible and well tolerated with improved target delineation utilizing both MRI and PET fusion with an acceptable toxicity profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Dose Level 1 - 66 Gy | Experimental | 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)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. |
| Arm 2: Dose Level 2 - 69 Gy | Experimental | 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)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. |
| Arm 3: Dose Level 3 - 72 Gy | Experimental | 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)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. |
| Arm 4: Dose Level 4 - 75 Gy | Experimental | 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)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. |
| MTD Expansion Cohort | Experimental | 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
Key exclusion criteria (10 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ⁶⁸Ga-Dotatate PET and MRI Guided Radiation TherapyThe radiation dose levels will be 66, 69, 72, and 75 Gy in 30 daily fractions based on the design. | Radiation | 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)Also: MRIMRI 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 | 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 ImagingAlso: GaTate PET, Gallium-68 DOTATATE Scan, DOTA-TATE imaging⁶⁸(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. | Diagnostic test | 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)Also: SurveyEvery 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. | Other | 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)Also: SurveyEvery 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 | 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 |
Primary outcome
Maximum tolerated dose of 68Ga-Dotatate PET/MRI guided radiation dose escalation
Time frame: 30 days post-treatment
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).
8 secondary outcomes
Late Neurological Toxicities of Radiation Treatment
Time frame: up to 2 year post-treatment
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Time frame: Baseline
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Time frame: 3 months (+/- 2 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Time frame: 6 months (+/- 2 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Time frame: 9 months (+/- 2 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Time frame: 12 months (+/- 2 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Time frame: 18 months (+/- 4 weeks)
Symptom Burden Assessment Using MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Questionnaire
Time frame: 24 months (+/- 4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenyin Shi, MD, PhD principal investigator
Wenyin.Shi@jefferson.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ⁶⁸Ga-Dotatate PET and MRI Guided Radiation Therapy, Magnetic Resonance Imaging (MRI) and 68Ga-Dotatate PET Imaging in people with High Risk Meningioma and Recurrent Meningioma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of 68Ga-Dotatate PET/MRI guided radiation dose escalation (time frame: 30 days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.