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NCT03971461 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma

A Phase 2 study of Meningioma, sponsored by NYU Langone Health.

Active
Registry status
Phase 2
Development phase
32
Enrollment target
2
Study locations

NCT03971461 is a Phase 2 study of Meningioma that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 32 participants, below the 98-participant average among 21 other Meningioma trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03971461, a Phase 2 study of Meningioma, is active but no longer recruiting, sponsored by NYU Langone Health.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
32 participants
Enrollment target
2
Study locations

Study Summary

This single arm, open-label study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma. Ga-DOTATATE PET-MRI scans will be obtained prior to initiation of Lutathera treatment and 6 months after the initiation of Lutathera treatment. The latter will be performed within the 14 days prior to the last dose of Lutathera treatment.

Conditions Studied

Meningioma

Interventions

  • DRUG Lutathera

Study Locations (2)

New York

  • NYU Langone Health - New York

Ohio

  • Cleveland Clinic - Cleveland

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2019-05-15
Est. Completion 2027-01
Phase Phase 2

Sponsor

NYU Langone Health

1,164 total trials

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What the Registry Record Tells You About NCT03971461

The ClinicalTrials.gov registry entry for NCT03971461 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 21 other Meningioma trials with a reported enrollment target (67% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Meningioma appearing as the primary indexed condition, and to 1 intervention - of which Lutathera is the first listed.

NCT03971461 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, Ohio.

Frequently Asked Questions

What is clinical trial NCT03971461 about?

NCT03971461 is a clinical study titled "Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma". This single arm, open-label study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma. Ga-DOTATATE PET-MRI scans will be obtained ...

What is the current status of trial NCT03971461?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2019-05-15. Estimated completion is 2027-01.

What conditions does trial NCT03971461 study?

This clinical trial studies the following conditions: Meningioma.

What interventions are being tested in trial NCT03971461?

The interventions under investigation include: Lutathera (DRUG).

Who is sponsoring clinical trial NCT03971461?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03971461 being conducted?

This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.