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NCT04040569 · ClinicalTrials.gov registry record · Phase 1

A Phase I Dose Escalation Study of Single Fraction Pre-operative Partial Breast (S-PBI) for Early Stage Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.

Active
Registry status
Phase 1
Development phase
45
Enrollment target
1
Study location

NCT04040569 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 45 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04040569, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
45 participants
Enrollment target
1
Study location

Study Summary

The purpose of this phase I trial is to evaluate dose-limiting toxicity while dose escalating single-fraction preoperative S-PBI to a presumed radioablative dose over 3 cohorts, starting with 30Gy in 1 fraction and advancing to 34Gy and 38Gy in 1 fraction.

Conditions Studied

Interventions

  • RADIATION Radiomics on MRI

Study Locations (1)

Texas

  • University of Texas Southwestern Medical Center - Dallas - Dallas

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2019-12-25
Est. Completion 2027-07
Phase Phase 1

What the Registry Record Tells You About NCT04040569

The ClinicalTrials.gov registry entry for NCT04040569 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Radiomics on MRI is the first listed.

NCT04040569 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT04040569 about?

NCT04040569 is a clinical study titled "A Phase I Dose Escalation Study of Single Fraction Pre-operative Partial Breast (S-PBI) for Early Stage Breast Cancer". The purpose of this phase I trial is to evaluate dose-limiting toxicity while dose escalating single-fraction preoperative S-PBI to a presumed radioablative dose over 3 cohorts, starting with 30Gy in 1 fraction and advancing to 34Gy and 38Gy in 1 fraction.

What is the current status of trial NCT04040569?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2019-12-25. Estimated completion is 2027-07.

What conditions does trial NCT04040569 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT04040569?

The interventions under investigation include: Radiomics on MRI (RADIATION).

Who is sponsoring clinical trial NCT04040569?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04040569 being conducted?

This trial has 1 study location across Texas. 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

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