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NCT03778294 · ClinicalTrials.gov registry record · Phase 2

18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy

A Phase 2 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
43
Enrollment target

NCT03778294: Completed Phase 2 study, sponsored by Mayo Clinic.

NCT03778294 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03778294, a Phase 2 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
43 participants
Enrollment target

Study Summary

This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the radiation doctor with information on tumor tissue versus normal, healthy tissue and may help the doctor more accurately plan the radiation treatment.

Primary Outcome

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).

Interventions

  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Positron Emission Tomography
  • RADIATION Proton Beam Radiation Therapy
  • OTHER Fluorodopa F 18

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2019-03-28
Est. Completion 2023-11-26
Phase Phase 2
Mayo Clinic

2,844 total trials

What the finished NCT03778294 record still lists

NCT03778294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 5 interventions - of which Computed Tomography is the first listed.

NCT03778294 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03778294 about?

NCT03778294 is a clinical study titled "18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy". This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy. 1...

What is the current status of trial NCT03778294?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2019-03-28. Estimated completion is 2023-11-26.

What interventions are being tested in trial NCT03778294?

The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Proton Beam Radiation Therapy (RADIATION), Fluorodopa F 18 (OTHER).

Who is sponsoring clinical trial NCT03778294?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03778294's enrollment target sits among peer trials

43 1332nd of 2000 higher than 662 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03778294, the US trial registry maintained by the National Library of Medicine. NCT03778294 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.