Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332508
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2022-10-07
Brief Title:
Pulsed Electromagnetic Fields PEMFs - A Highly Selective Breast CAncer Treatment pLatform PASCAL
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Pulsed Electromagnetic Fields PEMFs - A Highly Selective Breast CAncer Treatment pLatform PASCAL First-in-man Phase 1 Safety Trials
Status:
RECRUITING
Status Verified Date:
2024-03
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:
To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment
Detailed Description:
This is a single-center phase Ib study to investigate the safety and tolerability of the combination of PEMF with anthracycline-based chemotherapy Subjects will be enrolled on a 33 dose escalation design from dose level 1 with a target to reach dose level 4 where PEMF can be administered prior to each cycle of anthracycline-based chemotherapy In the first 2 dose levels PEMFs will first be administered to subjects who are planned for upfront surgical resection to ensure that PEMFs is safe and tolerable for up to 05-hour Once the duration of each PEMF treatment is established PEMFs will then be added to anthracycline-based chemotherapy to investigate the safety and tolerability of the combination treatment
Study Oversight
Has Oversight DMC:
None
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?:
None