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

NCT00321048 | Completed Results

• 2 other identifiers: J0609NA_00002394
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms; Carcinoma, Ductal; Adenocarcinoma

Keywords

breast cancer; SPECT; ABC device; Invasive adenocarcinoma of the left breast; Ductal Carcinoma In Situ of the left breast

Outcome Measures

Primary Outcomes (1)

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

  Efficacy of the ABC device in protecting the heart from radiation (XRT) damage in patients with L breast cancer is determined by the change in cardiac perfusion (mean apical perfusion score) as measured by SPECT between baseline and 6 month follow up. A score of 1 represents an equivocal or mild reduction in perfusion, 2 represents moderately reduced perfusion, 3 represents severely reduced perfusion, and 4 indicates absent perfusion.

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

Study Arms (2)

ABC (Active Breathing coordinator)

EXPERIMENTAL

Patients are randomized to ABC arm will receive radiation with ABC. Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the No ABC arm.

Device: Active Breathing Coordinator

No Active Breathing Coordinator

NO INTERVENTION

Patients randomized to the No ABC arm will receive radiation without ABC.Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the ABC arm.

Interventions

Active Breathing Coordinator DEVICE

A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.

ABC (Active Breathing coordinator)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients requiring oxygen
• Sarcoma or Squamous Cell pathology
• Right-sided breast cancers
• Metastatic disease to the breast

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Breast Cancer Research Foundation: collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Zellars R, Bravo PE, Tryggestad E, Hopfer K, Myers L, Tahari A, Asrari F, Ziessman H, Garrett-Mayer E. SPECT analysis of cardiac perfusion changes after whole-breast/chest wall radiation therapy with or without active breathing coordinator: results of a randomized phase 3 trial. Int J Radiat Oncol Biol Phys. 2014 Mar 15;88(4):778-85. doi: 10.1016/j.ijrobp.2013.12.035.

  PMID: 24606847 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal; Adenocarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Results Point of Contact

• Title: Richard Zellars
• Organization: Indiana University

rzellars@iu.edu

3179444505

Study Officials

• Richard Zellars, M.D.

  Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Left breast/chest wall irradiation with or without ABC (active breathing coordinator)

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 28, 2025
• Results First Posted: June 19, 2019

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)