Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321048
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2006-05-01
Brief Title:
Spect Analysis of Cardiac Perfusion Changes After Whole BreastChest Wall Radiation Therapy With ABC
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Spect Analysis of Cardiac Perfusion Changes After Whole BreastChest Wall Radiation Therapy With Active Breathing Coordinator
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
50 left sided breast cancer patients will be randomized to receive breastchest wall irradiation with or without ABC Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy Treatments will be given Monday through Friday
After the completion of radiation therapy patients will be seen on the following schedule
A follow up examination will take place every 3-6 months for the first two years then every 4-6 months for years for the next 3 years After 5 years follow-up evaluations will occur annually A SPECT scan will be obtained at 6 months post therapy
Patients must be 18 and older and must have histologically confirmed by routine HE staining invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast
Patients must have also undergone a segmental mastectomy SM or Mastectomy
Patients must not have received prior radiation therapy to the breast at any time for any reason
Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen
After the completion of radiation therapy patients will be seen on the following schedule
A follow up examination will take place every 3-6 months for the first two years then every 4-6 months for years for the next 3 years After 5 years follow-up evaluations will occur annually A SPECT scan will be obtained at 6 months post therapy
Patients must be 18 and older and must have histologically confirmed by routine HE staining invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast
Patients must have also undergone a segmental mastectomy SM or Mastectomy
Patients must not have received prior radiation therapy to the breast at any time for any reason
Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NA_00002394 | OTHER | JHM IRB | None |