Actively Recruiting
Lutetium Lu 177 Dotatate (LUTATHERA) Treatment for Inoperable, Progressive Meningioma After Radiation Therapy Phase II Study
Led by Mayo Clinic ยท Updated on 2026-04-22
42
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating lutetium Lu 177 dotatate (LUTATHERA), a radioactive drug given through a vein, for treating patients with meningioma tumors that cannot be removed by surgery and have worsened after radiation therapy. This phase II study aims to find out if LUTATHERA is safe and effective in slowing tumor growth or improving survival in patients with different grades of recurrent meningioma. It also explores how well imaging methods can assess treatment response and how treatment affects patients' quality of life. Participants receive gallium Ga 68-DOTATATE intravenously and undergo PET/MRI or PET/CT scans before the first and fourth treatment cycles to evaluate tumor activity. They then get LUTATHERA through an IV infusion lasting 30 to 40 minutes every 8 weeks, for up to four cycles if the disease does not worsen and side effects are manageable. Additional imaging, including MRI, blood tests, and possibly SPECT/CT scans, are done during treatment to monitor effects and radiation dosing. During the study, patients have regular MRI scans, blood collections, and quality of life questionnaires. After completing treatment, participants are followed every 3 months for 2 years and then every 6 months up to 5 years to track progression-free survival, overall survival, and side effects. Researchers analyze treatment outcomes using standardized criteria and assess radiation doses to tumors and organs. The total involvement can last several years with close monitoring.
CONDITIONS
Brief Title
Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous treatment for meningioma including surgery if possible and radiation therapy
- Radiographic evidence of meningioma progression with measurable disease showing 15% or more increase in size over 6 months or new measurable lesion
- Prior fractionated radiation therapy or stereotactic radiosurgery with no safe option for further radiation
- Willingness to undergo 68Ga-DOTATATE PET imaging with Krenning score 2 or higher
- Measurable disease present
- ECOG performance status of 0, 1, or 2
- Adequate blood counts and liver function within 28 days before registration
- Calculated creatinine clearance of at least 40 ml/min
- Ability to complete questionnaires with or without assistance
- Provide written informed consent
- Willing to return for follow-up visits and possibly undergo SPECT/CT imaging for dosimetry analysis
You will not qualify if you...
- Eligible for surgical or curative radiation treatment
- Pregnant or nursing women, or men/women of childbearing potential unwilling to use contraception
- Severe concurrent illnesses that interfere with safety or assessment
- Contraindications or intolerance to MRI
- Immunocompromised patients or HIV positive receiving antiretroviral therapy
- Uncontrolled infections, heart failure, unstable angina, uncontrolled diabetes, arrhythmia, or psychiatric/social factors limiting compliance
- Receiving other investigational treatments for primary tumor
- Other active malignancy within 2 years except certain skin or cervical cancers
- Recent myocardial infarction or life-threatening heart arrhythmias
- Urinary incontinence preventing safe Lutathera administration
- Untreated or symptomatic toxicity from prior radiation including necrosis or optic neuropathy
- Optic nerve sheath meningioma or extracranial meningioma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 32 weeks (4 cycles every 8 weeks)
Participants receive lutetium Lu 177 dotatate intravenously every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Before cycles 1 and 4, participants receive gallium Ga 68-DOTATATE IV and undergo PET/MRI or PET/CT imaging. Blood samples and possible SPECT/CT dosimetry are collected during treatment.
4 treatment visits every 8 weeks plus 2 imaging visits before cycles 1 and 4
Duration - Up to 5 years
After treatment completion, participants are followed up every 3 months for 2 years and then every 6 months for up to 5 years to monitor overall and progression-free survival and assess adverse events.
Quarterly visits for 2 years, then semiannual visits up to 5 years
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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