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[18F]AlF-FAPI-74 PET/CT for preoperative assessment of the peritoneal cancer index and comparison with MRI-based, surgical and pathological assessment in colorectal cancer patients eligible for CRS-HIPEC: study protocol for a prospective observational pro

Por: van den Bos · M. · Vogel · W. V. · van Duijvenvoorde · M. · Kok · N. F. M. · Aalbers · A. G. J. · Snaebjornsson · P. · Lacle · M. M. · Willemse · J. R. J. · Kool · W. · Hendrikx · J. J. M. A. · de Hingh · I. H. J. T. · van Grevenstein · W. M. U. · Boerma · D. · Milne · A. N. · van
Introduction

Colorectal cancer patients with peritoneal metastases have a very poor prognosis. A minority of these patients is eligible for curative cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The peritoneal cancer index (PCI) is an important criterion to select patients for CRS-HIPEC. Due to challenges in peritoneal metastasis detection by imaging, the PCI is currently routinely assessed by invasive diagnostic laparoscopy in addition to CT and/or MRI. Yet, open-close procedures and early disease recurrence following CRS-HIPEC are common, indicating the need for better patient selection tools. Fibroblast activation protein (FAP)-targeted imaging has recently emerged as a promising strategy for visualising peritoneal disease. The aim of this study is to assess the potential value of FAP inhibitor positron emission tomography/CT (FAPI-PET/CT) as an alternative non-invasive tool for quantitative PCI assessment.

Methods and analysis

TROMPET is a prospective observational proof-of-concept study. A total of 25 colorectal cancer patients with suspected or verified peritoneal metastases who are eligible for CRS-HIPEC based on MRI will be included in this study. Patients younger than 18, pregnant and/or breastfeeding, with any contraindication(s) for MRI, PET, CT and/or CRS-HIPEC, and/or with a known additional malignancy within the past five years are excluded. Participants will receive [18F]AlF-FAPI-74 PET/CT prior to surgery. The primary objective is to determine the correlation between PCI scores determined by FAPI-PET/CT and ‘true’ PCI scores determined by histopathological analysis of all resected lesions. The secondary objectives include the correlations between PCI scores determined by FAPI-PET/CT, by MRI and during surgery, the potential of FAPI-PET/CT to detect extraperitoneal metastases, and molecular and immunohistochemical analysis of resected tissue to provide insight into the nature of FAPI-PET-positive lesions. The primary endpoint is all PCI scores determined by FAPI-PET and histopathology and their correlation on patient level. If this study shows that the PCI score can be accurately determined preoperatively by FAPI-PET/CT, it will form the basis for further developing FAPI-PET/CT as a quantitative, standardised, non-invasive diagnostic tool for selecting patients for CRS-HIPEC. Moreover, the ‘radiology-pathology’ setup of the study will allow us to characterise FAPI-PET-positive and PET-negative lesions in detail, providing further insight into the strengths and potential pitfalls of FAPI-PET/CT in the detection of peritoneal metastases from colorectal cancer.

Ethics and dissemination

This study is approved by the assigned Medical-Research-Ethics-Committee (METC NedMec) on 19-08-2024. All participants will provide written informed consent. Study results will be disseminated through (inter)national meetings and peer-reviewed publications.

Trial registration number

2024-512301-16-01

Understanding parents decisions to seek care for children with serious bacterial infections: a qualitative study

Por: van Kempen · E. B. · Willemsen · M. · Oostenbrink · R. · van Veen · M.
Objective

To explore which factor or combination of factors is perceived by parents as most distinctive in prompting them to seek medical care for children aged 0–5 years who were admitted to the hospital with fever due to a serious bacterial infection (SBI), in order to inform further development of an e-health tool.

Design

A qualitative study was conducted using semi-structured interviews with a purposive sampling strategy. Interviews were conducted by a medical intern and supervised by a clinician researcher. Interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis to identify key themes in parental decision-making.

Setting

Paediatric ward of the Juliana Children’s Hospital in The Hague, an urban teaching hospital in the Netherlands, between April and June 2024.

Participants

Parents of children aged 0–5 years admitted with a suspected SBI were eligible. Of the 17 parents approached, 15 agreed to participate in 13 interviews (ie, in two interviews both parents participated).

Results

13 interviews with 15 parents revealed five themes. Parents sought medical attention when they perceived a shift in their child’s illness state, based on three themes: perceived abnormal illness presentation through either single alarming symptoms (altered consciousness, breathing difficulties, skin changes) or symptom combination, symptom recognition based on previous experiences or prolonged fever and respiratory complaints. Many parents demonstrated awareness of symptoms aligning with professional red flag indicators. The fourth and fifth themes, work constraints and limited general practitioner access, highlighted external barriers that sometimes delayed help-seeking.

Conclusion

This study highlights key factors influencing parents’ decisions to seek medical care for febrile children with an SBI, emphasising the importance of both parental perceptions and clinical symptoms. The findings may inform parent-centred resources including an e-health tool, which support parents in assessing illness severity and deciding when to seek medical care.

Capturing risk awareness and disease burden in cardiovascular (risk) management: development and content validation of a new module for the Assessment of Burden of Chronic Conditions (ABCC)-tool

Por: Debie · V. H. · Ottenheijm · R. P. · Gruiskens · J. · Mikulic · S. · van Schayck · O. C. · Muris · J. W. · Willemsen · R. T. A. · Kroon · A. · Gidding-Slok · A. H.
Objectives

Cardiovascular disease (CVD) is the leading cause of death worldwide and is associated with a broad range of physical, emotional and social burdens. Existing tools such as Systematic Coronary Risk Evaluation and WHO CVD risk charts identify clinical risk factors but fail to capture patient-perceived burden and the risk of burden awareness. The Assessment of Burden of Chronic Conditions (ABCC)-tool, a validated, person-centred instrument, offers a more holistic approach. The aim of the current study is to develop and validate a new module within the ABCC-tool for patients with an elevated cardiovascular (CV) risk or CVD (cardiovascular risk management (CVRM) module).

Design and setting

A mixed-methods design was used across four phases and expert meetings to identify the items for the module. All phases took place in the Netherlands. Phase 1 (literature search) was performed in 2021, phase 2 (semistructured interviews) was completed between January and October 2021, phase 3 (survey) was completed in November 2023 and December 2024, and phase 4 (semistructured interviews) was completed in January 2025.

Participants

Phase 2 involved 14 experts by experience (patients with CVD or people at elevated risk) and 10 healthcare professionals in the field of CVD. Phase 3 included 86 healthcare professionals. Phase 4 included 12 experts by experience. In total, four expert meetings took place, attended by three experts by experience, nine healthcare professionals and seven researchers.

Outcome measures

The module was refined iteratively, using qualitative and quantitative insights at each phase of development. The model was only finalised after thorough content validation.

Results

No suitable patient-reported outcome measures (PROMs) focusing specifically on CVRM were identified in the literature. Interviews revealed significant burdens in terms of physical, emotional and social burdens. Feedback from expert meetings and validation rounds led to substantive refinement. The final module contains 10 items and was deemed valid by both experts by experience and healthcare professionals.

Conclusion

The CVRM module of the ABCC-tool has been systematically developed and validated in terms of content. The final module focuses on the multidimensional burden of CVD and dealing with its risk factors and aims to support self-management. The module complements existing risk assessment tools by focusing on the burden experienced by the patient and the burden resulting from risk awareness.

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