Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597045
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
BIOMARKER and IMAGING CHARACTERISATION of INFLAMMATORY ATHEROMA in PATIENTS RECEIVING IMMUNOTHERAPY and ANGIOGENESIS INHIBITORS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
BIOMARKER and IMAGING CHARACTERISATION of INFLAMMATORY ATHEROMA in PATIENTS RECEIVING IMMUNOTHERAPY and ANGIOGENESIS INHIBITORS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOCAPRI
Brief Summary:
The advent of immunotherapy immune checkpoint inhibitors ICI has been an extremely important advancement for cancer treatment in recent decades The anti-cancer effects of these agents is profound and can lead to radiological 39disappearance39 of the primary cancer and metastatic deposits ICI are now commonly used in the treatment of multiple cancers including melanoma kidney cancer liver cancer and lung cancer ICI can be used on their own or in combination with other agents such as vascular endothelial growth factor inhibitors VEGFi which is first line treatment for many patients However it has become clear that these drugs have cardiovascular side effects including high blood pressure and a reduction in the heart muscle pumping function It is also increasingly recognised that ICIs may have a toxic effect on blood vessels resulting in an increased risk of heart attack or stroke These side effects can have a significant impact on patients39 health and can lead to withdrawal of important cancer treatment The mechanisms by which these side effects occur are unclear and have not been well described to date
The aim of this study is to examine the effect of ICI and VEGFi both alone and in combination on blood vessels and to understand their effects on blood markers and heart function This study is observational and will not require any modification of cancer therapy
This study will aim to recruit patients diagnosed with cancer who are already planned to receive ICI or VEGFi alone or in combination at the Beatson West of Scotland Oncology Centre Patients will undergo a vascular PET-CT scan before and 6 months after starting treatment In addition patients will undergo echocardiography and tests of the function of the small blood vessels in the fingertips with a special machine EndoPat Blood and urine samples will also be collected
The aim of this study is to examine the effect of ICI and VEGFi both alone and in combination on blood vessels and to understand their effects on blood markers and heart function This study is observational and will not require any modification of cancer therapy
This study will aim to recruit patients diagnosed with cancer who are already planned to receive ICI or VEGFi alone or in combination at the Beatson West of Scotland Oncology Centre Patients will undergo a vascular PET-CT scan before and 6 months after starting treatment In addition patients will undergo echocardiography and tests of the function of the small blood vessels in the fingertips with a special machine EndoPat Blood and urine samples will also be collected
Detailed Description:
None
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