Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04595435 · ClinicalTrials.gov registry record

IORT-Breast at Medical Center Navicent Health

A clinical trial of Breast Cancer Female and Early Stage Breast Cancer, sponsored by Wake Forest University Health Sciences.

Active
Registry status
94
Enrollment target
1
Study location

NCT04595435 is a study of Breast Cancer Female and Early Stage Breast Cancer that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 94 participants, below the 691-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04595435, a study of Breast Cancer Female and Early Stage Breast Cancer, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.

ACTIVE NOT RECRUITING
Registry status
94 participants
Enrollment target
1
Study location

Study Summary

Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes. Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance

Interventions

  • PROCEDURE Lumpectomy
  • RADIATION Intraoperative Radiation Therapy

Study Locations (1)

Georgia

  • Medical Center, Navicent Health - Macon

Trial Details

FieldValue
Enrollment Target 94 participants
Start Date 2019-03-19
Est. Completion 2033-12-31

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT04595435

The ClinicalTrials.gov registry entry for NCT04595435 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 691-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (86% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Cancer Female appearing as the primary indexed condition, and to 2 interventions - of which Lumpectomy is the first listed.

NCT04595435 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT04595435 about?

NCT04595435 is a clinical study titled "IORT-Breast at Medical Center Navicent Health". Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT t...

What is the current status of trial NCT04595435?

This trial is currently active not recruiting. The enrollment target is 94 participants. The study started on 2019-03-19. Estimated completion is 2033-12-31.

What conditions does trial NCT04595435 study?

This clinical trial studies the following conditions: Breast Cancer Female, Early Stage Breast Cancer.

What interventions are being tested in trial NCT04595435?

The interventions under investigation include: Lumpectomy (PROCEDURE), Intraoperative Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT04595435?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04595435 being conducted?

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

Similar trials for Breast Cancer Female

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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.