An observational study in Cancer, Cardiotoxicity and Atherosclerotic Disease, sponsored by NHS Greater Glasgow and Clyde. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by NHS Greater Glasgow and Clyde · Observational
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 \'disappearance\' 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\' 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.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 60 is below the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →NHS Greater Glasgow and Clyde is the lead sponsor of 220 studies on the registry; 39 are open to participants now.
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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.
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Exclusion Criteria:
Patients who are given immune checkpoint inhibitor (ICI) monotherapy (decision on treatment is made by the clinical oncology team. Enrolment to this study had no influence or impact on choice of anti-cancer therapy. Patients were allocated this group if they received at least one cycle of immune check point inhibitor. In the event that a patient is given ICI/VEGFI combination therapy but the VEGFi was stopped early (due to toxicity or lack of clinical effect, determined by the clinical team) and they had less than 50% exposure to VEGFi in the protocol window (24 weeks), the patient will be allocated to ICI monotherapy. Subsequent sensitivity analyses looking at any exposure to VEGFI vs those who had no exposure will be performed.
Diagnostic Test: PET/CT with 18-FDG
Patients who are given VEGF inhibitor monotherapy (decision on treatment is made by the clinical oncology team. Enrolment to this study had no influence or impact on choice of anti-cancer therapy Patients will be allocated this group if they are given VEGFi with no exposure to immunotherapy in the study period. If patients are enrolled in the study but stop VEGF inhibitor early they will still be included in this group, provided they do not receive immune checkpoint inhibitor. If during the study protocol window, the patient is exposed to other anti-cancer therapies (other than ICI), in addition to VEGF inhibitor, they will be remain in the VEGFI group.
Diagnostic Test: PET/CT with 18-FDG
Patients who are given immune checkpoint inhibitor / VEGF inhibitor combination therapy (decision on treatment is made by the clinical oncology team. Enrolment to this study had no influence or impact on choice of anti-cancer therapy). Patients were allocated this group if they received at least one cycle of immune check point inhibitor and VEGFI with more than 50% of the exposure in the study protocol window (24 weeks). Subsequent sensitivity analyses looking at any exposure to VEGFI vs those who had no exposure will be performed.
Diagnostic Test: PET/CT with 18-FDG
Study specific tests will include 18F-FDG PET/CT (specialised CT scan), electrocardiography (ECG), clinic blood pressure assessment, blood tests, urine sample, echocardiography (heart ultrasound) and tests on the fingertips (EndoPAT). Positron emission tomography with computerised tomography (PET-CT) is a scanning technique in routine clinical use. It is the gold standard method for assessing blood vessel inflammation. A small amount of radioactive sugar (18F-FDG \[18F- fluorodeoxyglucose\]) is administered intravenously 90 minutes prior to the PET-CT scan. The distribution of uptake of this tracer is seen on the subsequent PET-CT scan. The CT component of this scan allows the PET image to be precisely aligned with anatomical structures (especially large blood vessels).
Also known as: blood and urine biomarkers, endopat, echocardiography
Mean arterial TBRmax 18F FDG uptake
Inflammatory plaque activity (meanMaxTBR)\* in patients receiving ICI/VEGFI combination therapy versus ICI alone or VEGFI alone. \*Note \'meanMaxTBR\' is a PET measurement reflecting the average of the maximum \'target to background ratio \[TBR\]) where \'target\' denotes regions of PET radiotracer activity)
Time frame: 24 weeks
Blood and urine biomarker analysis
Correlation between baseline and longitudinal changes in humoral/urinary biomarkers as potential predictors of subsequent change in inflammatory plaque activity (TBR). Analysis of blood and urine biomarkers with inflammatory plaque activity (meanMaxTBR) in patients receiving ICI (alone or in combination) vs VEGFI alone.
Time frame: Baseline (pre-treatment) to 24 weeks
Inflammatory plaque activity (meanMaxTBR) in patients receiving ICI (alone or in combination) vs VEGFI alone.
In addition to ICI vs VEGFI vs ICI/VEGFI combination therapy, we will also compare PET activity in those who had ICI (monotherapy or combination therapy) with VEGFi monotherapy.
Time frame: Baseline (pre-treatment) to 24 weeks
PET activity with baseline cardiovascular risk factors and imaging (echo/CT)
Correlation between baseline cardiovascular risk factors and imaging (echo/CT) findings will be examined as predictors of subsequent change in inflammatory plaque activity (TBR).
Time frame: Baseline (pre-treatment) to 24 weeks
The effect of ICI/VEGFI upon endothelial function (EndoPAT) will be examined.
The effect of ICI/VEGFI upon endothelial function (EndoPAT) will be examined.
Time frame: Baseline (pre-treatment) to 24 weeks
PETCT 18F FDG uptake arterial analyses
In accordance with European Association of Nuclear Medicine guidelines, in addition to TBRmax, arteries will be analysed using TBRmean (tissue to background ratio mean FDG uptake), active segment; and most diseased segment.
Time frame: Baseline (pre-treatment) to 24 weeks
Started Aug 2022 (actual). Primary completion is estimated for Oct 2024, 25 months after the start.
Of 792 non-industry observational studies under Neoplasms, half reached primary completion within 102 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 352. This study's planned 25 months is below that.
Counting every sponsor, half of 884 studies reached it within 80 months; a quarter within 32 and three quarters within 318.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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