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RECRUITING
NCT06955169
PHASE2

Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment

Sponsor: RTOG Foundation, Inc.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, randomized, phase 2 clinical study to evaluate the efficacy of \[177Lu\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.

Official title: MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2025-12-24

Completion Date

2030-08

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

[177Lu]Lu-DOTATATE

The treatment regimen consists of 4 (+2 optional) administrations of \[177Lu\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).

OTHER

Standard of Care treatments

Treatments will occur at the discretion and based on clinical judgement of the local and treating investigator. Local SOC therapy with one of the following agents: bevacizumab, everolimus, hydroxyurea, or sunitinib.

Locations (10)

Yale University

New Haven, Connecticut, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Baptist Health Medical Group Oncology

Miami, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

Dana-Farber/Harvard Cancer Center

Boston, Massachusetts, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States