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RECRUITING Phase 1

STARLITE for Unresectable High-Grade Gliomas

NCT06428045 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.

Conditions Studied

Interventions

  • DRUG Temozolomide
  • PROCEDURE Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT)
  • DRUG Abacavir
  • DRUG Lamivudine
  • DRUG Ritonavir

Study Locations (1)

Florida

  • University of Miami — Miami

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2025-04-15
Est. Completion 2030-04-30
Phase Phase 1

Sponsor

University of Miami

667 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06428045

The ClinicalTrials.gov registry entry for NCT06428045 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 667 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with High Grade Glioma appearing as the primary indexed condition, and to 5 interventions — of which Temozolomide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06428045 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06428045 about?

NCT06428045 is a clinical study titled "STARLITE for Unresectable High-Grade Gliomas". The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grad...

What is the current status of trial NCT06428045?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-04-15. Estimated completion is 2030-04-30.

What conditions does trial NCT06428045 study?

This clinical trial studies the following conditions: High Grade Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06428045?

The interventions under investigation include: Temozolomide (DRUG), Magnetic Resonance (MR)-guided Laser Interstitial Thermal Therapy (LITT) (PROCEDURE), Abacavir (DRUG), Lamivudine (DRUG), Ritonavir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06428045?

This trial is sponsored by University of Miami, which has 667 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06428045 being conducted?

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

Related

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