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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 is a NA study that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 150 participants.
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.
Interventions
- OTHER CT simulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-09 |
| Est. Completion | 2020-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03037723
The ClinicalTrials.gov registry entry for NCT03037723 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Upstate Medical University, which has 113 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CT simulation is the first listed.
NCT03037723 reports 0 study locations.
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.
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