Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774886
Status:
WITHDRAWN
Last Update Posted:
2023-05-18
First Post:
2023-01-31
Brief Title:
Implantable Microdevice for TNBC - Pilot Study
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Pilot Study of an Implantable Microdevice to Evaluate Drug Responses in Situ in Early-stage Triple-negative Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
On hold
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to evaluate the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of a specific drug or combination of drugs as a possible tool to evaluate the effectiveness of several cancer drugs against early stage Triple Negative Breast Cancer TNBC
The name of the intervention involved in this study is
Implantable Microdevice IMD
The name of the intervention involved in this study is
Implantable Microdevice IMD
Detailed Description:
This is a single-arm pilot research study to evaluate the safety and feasibility of using an implantable microdevice to measure local intratumoral response to chemotherapy and other clinically relevant drugs in triple-negative breast cancer TNBC A pilot study means that this is the first time investigators are examining this study intervention in TNBC Participants selected for this study must have a diagnosis of Stage II-III TNBC and are scheduled to undergo neoadjuvant systemic therapy
This study involves implanting 2 microdevices each small enough to fit inside the tip of a needle into a tumor The microdevices will release microdoses of up to 30 different cancer drugs via passive diffusion The drugs will only penetrate the local tumor tissues After approximately 72 hours the microdevices and small regions of surrounding tissue will be removed and studied
The US Food and Drug Administration FDA has not approved the microdevice as treatment for any disease For this study the drugs used are agents approved by the US FDA for the treatment of different types of cancer
The research study procedures include screening for eligibility study treatment with evaluations radiology scans of tumors blood tests tumor biopsies mammograms and follow-up visits
It is expected that about 24 people will take part in this research study
Participants will be followed on this study for up to 3 years
This study involves implanting 2 microdevices each small enough to fit inside the tip of a needle into a tumor The microdevices will release microdoses of up to 30 different cancer drugs via passive diffusion The drugs will only penetrate the local tumor tissues After approximately 72 hours the microdevices and small regions of surrounding tissue will be removed and studied
The US Food and Drug Administration FDA has not approved the microdevice as treatment for any disease For this study the drugs used are agents approved by the US FDA for the treatment of different types of cancer
The research study procedures include screening for eligibility study treatment with evaluations radiology scans of tumors blood tests tumor biopsies mammograms and follow-up visits
It is expected that about 24 people will take part in this research study
Participants will be followed on this study for up to 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None