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NCT04846309 · ClinicalTrials.gov registry record · Phase 1

Hypoxia Imaging for Esophageal Cancer to Guide Personalized Radiation Therapy

A Phase 1 study of Esophageal Cancer, sponsored by University of Utah.

Recruiting
Registry status
Phase 1
Development phase
16
Enrollment target
1
Study location

NCT04846309 is a Phase 1 study of Esophageal Cancer that is actively recruiting participants, run by University of Utah. The registered enrollment target is 16 participants, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04846309, a Phase 1 study of Esophageal Cancer, is actively recruiting participants, sponsored by University of Utah.

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

Study Summary

This is a Phase I trial evaluating the safety of personalized radiation therapy based on levels of hypoxia identified on FMISO-PET and MRI. All patients will receive a baseline FMISO positron emission tomography (PET) and MRI to identify levels of hypoxia. Patients with tumor hypoxia will receive a higher dose of radiation therapy. Subjects who do not have hypoxic tumors will be treated with the standard-of-care radiation regimen. After fraction 10 of radiation therapy, an additional MRI will be performed. If this interim MRI demonstrates little or no response (as defined in Section 6), an optional boost radiation dose can be administered. Trial enrollment will be conducted in two parts. In Part 1, eight patients will be enrolled. After all eight patients have completed the 30 day dose-limiting toxicity (DLT) period, enrollment will be placed on hold and safety will be evaluated. During the interim analysis, one additional patient will be allowed to be enrolled in the trial. If the trial meets stopping rules as described in Section 11.3, the trial will be re-evaluated by the Data and Safety Monitoring Committee (DSMC) and the Principal Investigator. However, if the rate of DLTs remains below the unacceptable toxicity rate, enrollment will open to the enrollment of eight more patients.

Conditions Studied

Esophageal Cancer

Interventions

  • RADIATION Radiation
  • DRUG FMISO PET CT

Study Locations (1)

Utah

  • Huntsman Cancer Institute - Salt Lake City

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2021-10-12
Est. Completion 2027-04
Phase Phase 1

Sponsor

University of Utah

818 total trials

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What the Registry Record Tells You About NCT04846309

The ClinicalTrials.gov registry entry for NCT04846309 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (97% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Esophageal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Radiation is the first listed.

NCT04846309 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.

Frequently Asked Questions

What is clinical trial NCT04846309 about?

NCT04846309 is a clinical study titled "Hypoxia Imaging for Esophageal Cancer to Guide Personalized Radiation Therapy". This is a Phase I trial evaluating the safety of personalized radiation therapy based on levels of hypoxia identified on FMISO-PET and MRI. All patients will receive a baseline FMISO positron emission tomography (PET) and MRI to identify levels of hypoxia. Patients with tumor hypoxia will receive a ...

What is the current status of trial NCT04846309?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-10-12. Estimated completion is 2027-04.

What conditions does trial NCT04846309 study?

This clinical trial studies the following conditions: Esophageal Cancer.

What interventions are being tested in trial NCT04846309?

The interventions under investigation include: Radiation (RADIATION), FMISO PET CT (DRUG).

Who is sponsoring clinical trial NCT04846309?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04846309 being conducted?

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

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

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.