Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:17 AM
Study NCT ID:
NCT05483712
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2022-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy
Sponsor:
Nova Scotia Cancer Centre
Organization:
Study Overview
Official Title:
A Clinical Trial to Assess Skin Dose in Post-mastectomy Adjuvant Radiation Therapy of Breast Cancer Patients Using a Brass Mesh Bolus
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery.
Detailed Description:
Intervention: During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.
Comparator: Superflab and no bolus applied as per the treating physician's practice, typically on alternate days. The intervention and comparator tools are to be utilized on each participant.
Primary outcome
1. To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care).
2. To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.
Comparator: Superflab and no bolus applied as per the treating physician's practice, typically on alternate days. The intervention and comparator tools are to be utilized on each participant.
Primary outcome
1. To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care).
2. To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: