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NCT04559685 · ClinicalTrials.gov registry record · Early Phase 1

Study of Sonodynamic Therapy in Participants with Recurrent High-Grade Glioma

A Early Phase 1 study of High Grade Glioma, sponsored by Nader Sanai.

Recruiting
Registry status
Early Phase 1
Development phase
30
Enrollment target
1
Study location

NCT04559685 is a Early Phase 1 study of High Grade Glioma that is actively recruiting participants, run by Nader Sanai. The registered enrollment target is 30 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04559685, a Early Phase 1 study of High Grade Glioma, is actively recruiting participants, sponsored by Nader Sanai.

RECRUITING
Registry status
Early Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be administered intravenous (IV) aminolevulinic acid HCl (ALA) approximately six to seven (6-7) hours prior to receiving sonodynamic therapy (SDT).

Conditions Studied

High Grade Glioma

Interventions

  • COMBINATION_PRODUCT SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)
  • DEVICE MR-Guided Focused Ultrasound device (MRgFUS)

Study Locations (1)

Arizona

  • St. Joseph's Hospital and Medical Center - Phoenix

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-03-15
Est. Completion 2028-03-31
Phase Early Phase 1

Sponsor

Nader Sanai

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04559685

The ClinicalTrials.gov registry entry for NCT04559685 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (54% lower). The listed sponsor is Nader Sanai, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with High Grade Glioma appearing as the primary indexed condition, and to 2 interventions - of which SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) is the first listed.

NCT04559685 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT04559685 about?

NCT04559685 is a clinical study titled "Study of Sonodynamic Therapy in Participants with Recurrent High-Grade Glioma". A Phase 0 single center, first in human, open-label study of ascending energy doses of sonodynamic therapy (SDT) utilizing the MRgFUS combined with intravenous ALA to assess safety and efficacy in up to 45 participants with recurrent HGG. Eligible participants who are scheduled for resection will be...

What is the current status of trial NCT04559685?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2021-03-15. Estimated completion is 2028-03-31.

What conditions does trial NCT04559685 study?

This clinical trial studies the following conditions: High Grade Glioma.

What interventions are being tested in trial NCT04559685?

The interventions under investigation include: SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) (COMBINATION_PRODUCT), MR-Guided Focused Ultrasound device (MRgFUS) (DEVICE).

Who is sponsoring clinical trial NCT04559685?

This trial is sponsored by Nader Sanai, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04559685 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.