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NCT03037723 · ClinicalTrials.gov registry record · NA

Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy Imaging

A NA study, sponsored by State University of New York - Upstate Medical University.

Completed
Registry status
NA
Development phase
150
Enrollment target

NCT03037723: Completed NA study, sponsored by State University of New York - Upstate Medical University.

NCT03037723 is a NA study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03037723, a NA study, has completed, sponsored by State University of New York - Upstate Medical University.

COMPLETED
Registry status
NA
Development phase
150 participants
Enrollment target

Study Summary

Radiation therapy to the breast has remained a standard practice for breast conserving therapy. Because of the location of the heart and lungs when patients are positioned face-up, whole breast radiation therapy has been reported to increase the risk of damage to the heart a few years after treatment until at least 20 years after exposure, and may affect cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an increased risk for development of secondary lung malignancies. Recent studies have demonstrated a significant reduction in dose to the heart and lungs when treated in the face-down position. Similarly, correcting for the movement of breathing (respiratory gating) in the face-up position has also become an available option for reducing unwanted dose to the heart and lungs, particularly in left sided breast cancers. No study to date has compared these newer organ-sparing techniques head-to-head for early stage breast cancer. It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation. In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control. The treating physician will determine which of the two simulations, if any, offers better protection to each patients' heart and lungs. Two dosimetrists will be required to independently verify planned dosimetry with all treatment setups. Treatment will be planned in standard fashion using the best of the two plans.

Primary Outcome

dosimetric parameter

Interventions

  • OTHER CT simulation

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2013-09
Est. Completion 2020-12
Phase NA

What the finished NCT03037723 record still lists

NCT03037723 is an interventional study that assigns participants to a tested intervention. The registered 150 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 (89% lower).

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

NCT03037723 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03037723 about?

NCT03037723 is a clinical study titled "Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy Imaging". Radiation therapy to the breast has remained a standard practice for breast conserving therapy. Because of the location of the heart and lungs when patients are positioned face-up, whole breast radiation therapy has been reported to increase the risk of damage to the heart a few years after treatmen...

What is the current status of trial NCT03037723?

This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2013-09. Estimated completion is 2020-12.

What interventions are being tested in trial NCT03037723?

The interventions under investigation include: CT simulation (OTHER).

Who is sponsoring clinical trial NCT03037723?

This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03037723's enrollment target sits among peer trials

150 661st of 2000 higher than 1,299 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 NCT03037723, the US trial registry maintained by the National Library of Medicine. NCT03037723 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.