CompletedNot Applicable

Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC

United States57 participantsStarted 2006-06

Plain-language summary

Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.

Who can participate

Age range

18 Years – 100 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient must be 18 and older * Patients must have histologically confirmed (by routine H\&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast. * Patients must have undergone a segmental mastectomy (SM) or Mastectomy * Patients must not have received prior radiation therapy to the breast at any time for any reason. * Any patient with active local-regional disease prior to registration is not eligible. * Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy. * Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment. * All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * Patients requiring oxygen * Sarcoma or Squamous Cell pathology * Right-sided breast cancers * Metastatic disease to the breast

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score

Timeframe: Baseline (pre-radiation) to 6 months (post-radiation)

Trial details

NCT IDNCT00321048

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

Results submitted2019-05-24

View on ClinicalTrials.gov More Breast Neoplasms trials