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NCT00321048 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
NA
Development phase
57
Enrollment target

NCT00321048: Completed NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT00321048 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00321048, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
NA
Development phase
57 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE Active Breathing Coordinator

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2006-06
Est. Completion 2010-01
Phase NA

What the finished NCT00321048 record still lists

NCT00321048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Active Breathing Coordinator is the first listed.

NCT00321048 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00321048 about?

NCT00321048 is a clinical study titled "Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC". 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 wi...

What is the current status of trial NCT00321048?

This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2006-06. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00321048?

The interventions under investigation include: Active Breathing Coordinator (DEVICE).

Who is sponsoring clinical trial NCT00321048?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00321048's enrollment target sits among peer trials

57 1261st of 2000 higher than 739 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00321048, the US trial registry maintained by the National Library of Medicine. NCT00321048 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.