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NCT06444412 · ClinicalTrials.gov registry record · Phase 2
An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma
A Phase 2 study of WHO Grade 3 Glioma and WHO Grade 4 Glioma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06444412: Recruiting Phase 2 study of WHO Grade 3 Glioma and WHO Grade 4 Glioma, sponsored by Mayo Clinic.
NCT06444412 is a Phase 2 study of WHO Grade 3 Glioma and WHO Grade 4 Glioma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 71-participant average among 5 other WHO Grade 3 Glioma trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06444412, a Phase 2 study of WHO Grade 3 Glioma and WHO Grade 4 Glioma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a single scan. The PET scanner detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scanner uses x-rays to take structural pictures inside the body. PSMA PET also binds to neoplastic blood vessels, including those in gliomas. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for improving detection of tumor recurrence or progression, as opposed to treatment effects, in patients with gliomas.
Primary Outcome
Assessed as the percentage of patients who experience Grade 3 or higher adverse effects deemed to be at least possibly related to PSMA-11. Adverse effects will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Electronic Health Record Review
- DRUG Ga 68 PSMA-11
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-01-12 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
What NCT06444412 shows while recruiting
NCT06444412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 71-participant average among 5 other WHO Grade 3 Glioma trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with WHO Grade 3 Glioma appearing as the primary indexed condition, and to 4 interventions - of which Computed Tomography is the first listed.
NCT06444412 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06444412 about?
NCT06444412 is a clinical study titled "An Investigational Scan (Ga-68 PSMA-11 PET/CT) for Detection of Disease Recurrence or Progression in Patients With Glioma". This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spr...
What is the current status of trial NCT06444412?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2026-01-12. Estimated completion is 2028-07-31.
What conditions does trial NCT06444412 study?
This clinical trial studies the following conditions: WHO Grade 3 Glioma, WHO Grade 4 Glioma.
What interventions are being tested in trial NCT06444412?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Electronic Health Record Review (OTHER), Ga 68 PSMA-11 (DRUG).
Who is sponsoring clinical trial NCT06444412?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06444412 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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