Clinical trial NCT06597045: BIOMARKER and IMAGING CHARACTERISATION of INFLAMMATORY ATHEROMA in PATIENTS RECEIVING IMMUNOTHERAPY and ANGIOGENESIS INHIBITORS
Official title: BIOMARKER and IMAGING CHARACTERISATION of INFLAMMATORY ATHEROMA in PATIENTS RECEIVING IMMUNOTHERAPY and ANGIOGENESIS INHIBITORS
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Cardiotoxicity
Atherosclerotic Disease
Keywords: cancer
atherosclerosis
FDG
PETCT
cardiotoxicity
VEGFI
immune checkpoint inhibitor
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
name: University of Glasgow
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending oncology clinics at the the Beatson West of Scotland Oncology Centre with a diagnosis of cancer and planned for treatment with ICI and/or VEGFi therapies will be screened for entry into the study.

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 \&#39;disappearance\&#39; 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 patients\&#39; 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.


Eligibility criteria: Inclusion Criteria:

1. Patients with cancer who are planned for treatment with ICI or VEGFI, including combination therapy
2. ≥6 months predicted survival
3. Age ≥18 years

Exclusion Criteria:

1. Patients who are unable or unwilling to provide valid consent for the study
2. Patients with diabetes who are on oral anti-diabetic treatment or insulin at baseline
3. patients who have exposure to either immune checkpoint inhibitor or VEGF inhibitor in the 12 months before enrolment

Primary outcomes:
measure: Mean arterial TBRmax 18F FDG uptake
timeFrame: 24 weeks
Secondary outcomes:
measure: Blood and urine biomarker analysis
timeFrame: Baseline (pre-treatment) to 24 weeks
measure: Inflammatory plaque activity (meanMaxTBR) in patients receiving ICI (alone or in combination) vs VEGFI alone.
timeFrame: Baseline (pre-treatment) to 24 weeks
measure: PET activity with baseline cardiovascular risk factors and imaging (echo/CT)
timeFrame: Baseline (pre-treatment) to 24 weeks
measure: The effect of ICI/VEGFI upon endothelial function (EndoPAT) will be examined.
timeFrame: Baseline (pre-treatment) to 24 weeks
measure: PETCT 18F FDG uptake arterial analyses
timeFrame: Baseline (pre-treatment) to 24 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
Study officials:
References: