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Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy

NCT04082520 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-22

No results posted yet for this study

Summary

This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill tumor cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment. WHO Grade I and Cohort WHO II/III cohorts will be evaluated.

Conditions

  • Grade 1 Meningioma
  • Grade 2 Meningioma
  • Grade 3 Meningioma
  • Recurrent Meningioma
  • Unresectable Meningioma

Interventions

RADIATION

Gallium Ga 68-DOTATATE

Given IV

DRUG

Lutetium Lu 177 Dotatate

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/MRI

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Computed Tomography

Undergo PET/CT and/or SPECT/CT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Sponsors & Collaborators

Principal Investigators

  • Kenneth W. Merrell, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-14
Primary Completion
2027-09-04
Completion
2032-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04082520 on ClinicalTrials.gov