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NCT01189851 · ClinicalTrials.gov registry record · NA

Intraoperative Radiotherapy for Early Stage Breast Cancer

A NA study, sponsored by Hoag Memorial Hospital Presbyterian.

Completed
Registry status
NA
Development phase
200
Enrollment target

NCT01189851: Completed NA study, sponsored by Hoag Memorial Hospital Presbyterian.

NCT01189851 is a NA study that has completed, run by Hoag Memorial Hospital Presbyterian. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01189851, a NA study, has completed, sponsored by Hoag Memorial Hospital Presbyterian.

COMPLETED
Registry status
NA
Development phase
200 participants
Enrollment target

Study Summary

Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the extent of disease.

Primary Outcome

Invasive cancer margins \<1 mm and/or non-invasive cancer margins \< 2 mm are considered close or positive. Approximately 15% of patients treated with IORT have close or positive margins on pathologic assessment following IORT therapy and are recommended for additional therapy including re-excision, whole breast radiation or both.

Interventions

  • DEVICE Intraoperative Radiotherapy

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2010-06
Est. Completion 2023-12
Phase NA

What the finished NCT01189851 record still lists

NCT01189851 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 1 intervention - of which Intraoperative Radiotherapy is the first listed.

NCT01189851 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01189851 about?

NCT01189851 is a clinical study titled "Intraoperative Radiotherapy for Early Stage Breast Cancer". Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the extent of disease.

What is the current status of trial NCT01189851?

This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2010-06. Estimated completion is 2023-12.

What interventions are being tested in trial NCT01189851?

The interventions under investigation include: Intraoperative Radiotherapy (DEVICE).

Who is sponsoring clinical trial NCT01189851?

This trial is sponsored by Hoag Memorial Hospital Presbyterian, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01189851's enrollment target sits among peer trials

200 506th of 2000 higher than 1,434 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01189851, the US trial registry maintained by the National Library of Medicine. NCT01189851 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.