Breast Displacement and CT Radiation Dose

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary hypothesis of this study is that breast displacement out of the direct plane of imaging during computed tomography (CT) of the abdomen will reduce effective radiation dose to the female breast. Secondary hypotheses are that image noise and artifacts will also be decreased.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radiation Dose From Computed Tomography Before and After Implementation of a High Pitch Dual Spiral Technique

NCT01111760

Atherosclerosis of Coronary Artery Cardiovascular Disease Pulmonary Embolism +1 more

COMPLETED

Catheter Tip Position and Contrast Distribution Following Paravertebral Catheter Insertion: a CT Study

NCT07064317

Breast Cancer Patients

COMPLETED

Chest Trauma :Prediction of Thoracic Injuries Clinically and Radiologically

NCT03686579

Chest Trauma Fluid Balance; Disorder

UNKNOWN

Evaluating Validity of Clinical Criteria for Requesting Chest X-Rays in Trauma Patients

NCT01134744

Chest Trauma

COMPLETED

Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis

NCT02275143

Coronary Stenosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Computed tomography (CT) is a significant source of medical-related radiation, and radiation-related cancer risk is increasingly recognized in the medical and lay community. One of the groups at greatest risk for radiation-induced malignancies is young females due to the radiosensitivity of female breast tissue. Breast tissue frequently lies within the imaging plane for CT of the abdomen with limited gain in diagnostic information. We propose displacing this breast tissue out of the direct imaging plane will decrease unnecessary radiation exposure and may also indirectly improve image quality.

A device called Chrysalis has been designed and received FDA approval for the purposes of displacing female breast tissue during CT.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Computed Tomography Radiation Dosage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard CT

Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.

Group Type NO_INTERVENTION

No interventions assigned to this group

Chrysalis CT

Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.

Group Type EXPERIMENTAL

Chrysalis breast displacement device

Intervention Type DEVICE

Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chrysalis breast displacement device

Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* scheduled for CT of the abdomen and pelvis at Harborview Medical Center
* able to provide written informed consent

Exclusion Criteria

* Inability to provide written consent for self (minor, intubated, sedated, mentally incapacitated, in excessive physical distress)
* Chest or breast surgery within the previous 8 weeks
* Breast implants
* Open wounds to the chest wall
* Fractures of the ribs or spine within the previous 3 months
* Patients requiring oxygen therapy
* Mastectomy
* Breast radiation therapy
* Scarring to the breasts which would prevent displacement
* Claustrophobia is not an absolute exclusion criterion, but patient comfort will be a primary concern.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No