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NCT05560009 · ClinicalTrials.gov registry record

An Imaging Agent (Fluorodopa F 18) With Positron Emission Tomography/Magnetic Resonance Imaging for Assessing Treatment Response in Patients With High-Grade Soft Tissue Sarcomas

A clinical trial, sponsored by Mayo Clinic.

Completed
Registry status
9
Enrollment target

NCT05560009: Completed study, sponsored by Mayo Clinic.

NCT05560009 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05560009 has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
9 participants
Enrollment target

Study Summary

This study evaluates the use of a new imaging agent called fluorodopa F 18 (18F-DOPA) with positron emission tomography/magnetic resonance imaging (PET/MRI) for assessing treatment response in patients undergoing standard of care radiation therapy and/or surgery for high-grade soft tissue sarcomas that are new or that have come back (recurrent). Though there have been improvements in treatment options for soft tissue sarcomas, there is currently a need for a non-invasive way to determine a patient's potential benefit from receiving one of these treatments. 18F-DOPA with PET/MRI allows a patient's tumor to be visualized and their response to a given treatment assessed.

Primary Outcome

Correlated with pathologic response. The correlation between imaging measures and pathologic response will be evaluated using a logistic regression model for each one of the four imaging modalities separately. For each subject, 12-18 measures will be taken, and therefore, an exchangeable correlation structure will be used to model the correlation among the measures from the same patient. Giving the exploratory nature of the study, will not adjust for the multiple comparisons. Pathologic response

Interventions

  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Positron Emission Tomography
  • RADIATION Radiation Therapy
  • PROCEDURE Surgical Procedure
  • DRUG Fluorodopa F 18

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2022-11-10
Est. Completion 2024-07-09
Mayo Clinic

2,844 total trials

What the finished NCT05560009 record still lists

NCT05560009 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.

The record links to 0 conditions, and to 5 interventions - of which Magnetic Resonance Imaging is the first listed.

NCT05560009 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05560009 about?

NCT05560009 is a clinical study titled "An Imaging Agent (Fluorodopa F 18) With Positron Emission Tomography/Magnetic Resonance Imaging for Assessing Treatment Response in Patients With High-Grade Soft Tissue Sarcomas". This study evaluates the use of a new imaging agent called fluorodopa F 18 (18F-DOPA) with positron emission tomography/magnetic resonance imaging (PET/MRI) for assessing treatment response in patients undergoing standard of care radiation therapy and/or surgery for high-grade soft tissue sarcomas t...

What is the current status of trial NCT05560009?

This trial is currently completed. The enrollment target is 9 participants. The study started on 2022-11-10. Estimated completion is 2024-07-09.

What interventions are being tested in trial NCT05560009?

The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Radiation Therapy (RADIATION), Surgical Procedure (PROCEDURE), Fluorodopa F 18 (DRUG).

Who is sponsoring clinical trial NCT05560009?

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

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Source: ClinicalTrials.gov NCT05560009, the US trial registry maintained by the National Library of Medicine. NCT05560009 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.