The HeartSpare Study (Stage I)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Breast Cancer
Interventions
PROCEDURE

Voluntary deep-inspiratory breath hold

Patients undergoing scanning in v\_DIBH will be positioned supine with arms extended on a MedTec breast board. They will be monitored visually on screen and will be given a buzzer to press when they have taken a breath. CT images will be obtained during DIBH. If the patient needs to release their breath, they will be asked to press the buzzer a second time. Patients will be closely monitored by radiographers via CCTV.

PROCEDURE

Active-breathing-controlled deep-inspiratory breathhold

Patients undergoing scanning in ABC\_DIBH will be positioned supine with arms extended on a MedTec breast board to which an activated-breathing control device (Elekta, Crawley, UK) has been attached. They will breathe through the device. During ABC\_DIBH, CT images will be obtained.

PROCEDURE

Prone treatment

Patients undergoing scanning in a prone position will lie on a customised prone treatment platform. CT images will be acquired under free-breathing conditions.

DEVICE

Active-breathing-controlled deep-inspiratory breathhold

The ABC unit allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. The device consists of a mouthpiece connected to a pneumotachometer via a bidirectional valve and tubing. The air flow across the pneumotachometer is integrated and displayed on a computer monitor. The computer also controls a scissor valve which, when enabled, restricts air flow through the system, enabling the breath hold phase. The mouthpiece and air filter are patient specific, as is a nose clip that is used to ensure that patients are breathing through the device.

Trial Locations (1)

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
lead

Royal Marsden NHS Foundation Trust

OTHER

NCT02794324 - The HeartSpare Study (Stage I) | Biotech Hunter | Biotech Hunter