Breast Displacement and CT Radiation Dose (Chrysalis)

University of Washington

Status: Completed

Conditions: Radiation Dosage; Computed Tomography

Treatments: Device: Chrysalis breast displacement device

Study type: Interventional

Funder types: Other

Identifiers

NCT01261559

39071

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Standard CT

No Intervention group

Description:

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

Chrysalis CT

Experimental group

Description:

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.

Treatment:

Device: Chrysalis breast displacement device