Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204614
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-11
Brief Title:
Drug Screening Using IMD in Bladder Cancer
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Primary Bladder Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
This research study involves implanting up to 4 microdevices each small enough to fit inside the tip of a needle into a tumor These devices will release microdoses many thousands of times less than a treatment dose of different cancer drugs into the tumor After approximately 72 hours the devices and small regions of surrounding tissue will be removed and studied There will be a follow-up visit within 42 days of device removal to assess for potential safety issues or side effects
Detailed Description:
This is a phase I pilot study of microdevice implantation and retrieval in patients with primary bladder cancer The microdevice is 5x1mm and can be deployed using a biopsy needle placed percutaneously using imaging guidance The purpose of the microdevice is to measure local intratumor response to antitumor medications in patients with primary bladder cancer The microdevice contains multiple separate reservoirs that are each loaded with a specific drug or drug combination
Candidate patients will first be evaluated based on a CT or MRI obtained as part of clinical care and a physician who will determine whether the target lesion is amenable for microdevice implantation Microdevice implantation will occur via cystoscopy using a flexible grasper similar to that used for ureteral stent removal Several independent microdevices will be placed per patient and target lesion After implantation the reservoirs release microdoses of each drug allowing the drug to interact with the tumor tissue in its native microenvironment After device removal and before pathologic analysis a repeat plain film X-ray of the bladder will be obtained to evaluate for microdevice migration The microdevices will be removed along with the target tumor as part of standard-of-care surgical excision The tumor tissue surrounding the device will undergo pathologic and molecular analysis to assess local drug efficacy for each reservoir These analyses will explore the impact of drug treatment on local cellular processes eg apoptosis pathway signaling
The investigators will also investigate preliminary correlations between drug response as assessed by the microdevice and clinical outcomes and response to therapy Collectively these studies will establish the feasibility of clinical application of a drug-sensitivity microdevice in bladder cancer and the capacity of such a device to predict systemic response to cancer therapeutics
Candidate patients will first be evaluated based on a CT or MRI obtained as part of clinical care and a physician who will determine whether the target lesion is amenable for microdevice implantation Microdevice implantation will occur via cystoscopy using a flexible grasper similar to that used for ureteral stent removal Several independent microdevices will be placed per patient and target lesion After implantation the reservoirs release microdoses of each drug allowing the drug to interact with the tumor tissue in its native microenvironment After device removal and before pathologic analysis a repeat plain film X-ray of the bladder will be obtained to evaluate for microdevice migration The microdevices will be removed along with the target tumor as part of standard-of-care surgical excision The tumor tissue surrounding the device will undergo pathologic and molecular analysis to assess local drug efficacy for each reservoir These analyses will explore the impact of drug treatment on local cellular processes eg apoptosis pathway signaling
The investigators will also investigate preliminary correlations between drug response as assessed by the microdevice and clinical outcomes and response to therapy Collectively these studies will establish the feasibility of clinical application of a drug-sensitivity microdevice in bladder cancer and the capacity of such a device to predict systemic response to cancer therapeutics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None