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AnteayerBMJ Open

[89Zr]bevacizumab PET/CT imaging of vestibular schwannomas for the prediction of bevacizumab treatment effect in patients with symptomatic NF2-related schwannomatosis: a study protocol for a phase II single centre, prospective, feasibility trial

Por: Douwes · J. P. J. · Tops · A. L. · Dibbets-Schneider · P. · Verbist · B. M. · Fuentealba Bassaletti · C. A. · Jansen · J. C. · Koetsier · K. S. · van Dam · V. S. · Koot · R. W. · van Velden · F. H. P. · Pool · M. · Vugts · D. · Schopman · J. E. · Goeman · J. J. · De Geus-Oei · L.-F.
Introduction

Treatment with bevacizumab achieves both tumour stabilisation or regression and preservation or improvement of hearing. However, the efficacy of bevacizumab varies between patients and within patients. Side effects due to bevacizumab treatment are also common. It would be of value to predict therapeutic response prior to initiating therapy to prevent unnecessary exposure in patients unlikely to benefit.

Methods and analysis

We aim to recruit 25 patients with NF2-related schwannomatosis (NF2) with bilateral vestibular schwannomas. Patients will receive an intravenous injection of 37 MBq [89Zr]bevacizumab followed by positron emission tomography (PET)/CT imaging 4 days later. After clinical evaluation at baseline, patients undergo bevacizumab treatment and are followed up at 3 and 6 months. The primary objective is to examine associations between pretreatment [89Zr]bevacizumab uptake on PET/CT and changes in multiple hearing outcomes and radiological characteristics of the target tumour following treatment. Secondary outcome measures include vestibular functioning, patient reported outcome measures, cranial nerve functionality, peripheral neurology, non-target schwannoma response and renal function. Given the explorative nature of the study, associations between PET-derived metrics and clinical and radiological outcomes will be examined without formal hypothesis testing, using generalised estimating equations to account for within-patient correlation. Pairwise associations will be summarised in an association matrix with multiplicity addressed using an all-resolutions inference approach, and findings will be considered hypothesis generating.

Ethics and dissemination

This study was submitted via the Clinical Trials Information System reviewed and approved by the Medical Research Ethics Committee Leiden–The Hague–Delft Delft. The study findings will be disseminated through publication in peer-reviewed scientific journals and by presentation at national and international conferences.

Trial registration number

The trial is registered at ClinicalTrials.gov Protocol Registration and Results System under the registration ID: NCT05685836.

Cervical high-risk human papillomavirus infection and its associated risk factors: a community-based cross-sectional study in hard-to-reach areas in Bangladesh

Por: Nazrul · N. · Rahman · A. · de Fouw · M. · Campbell · C. · Koot · J. · Kulsum · M. U. · Ahmed · M. S. · Haider · S. S. · Hossain · M. A. · Islam · K. M. · Nessa · A. · Amrin · M. · Stekelenburg · J. · Beltman · J. J.
Objectives

This study aimed to determine the prevalence of cervical high-risk human papillomavirus (hrHPV) in a community-based setting and its risk factors association in women living in hard-to-reach areas in Bangladesh.

Design

A cross-sectional study

Setting

The study was carried out in six subdistricts, located in hard-to-reach and climate-impacted regions of Bangladesh.

Participants

A total of 8000 married women aged 30–60 years were invited for screening. Women who were unable to give consent, were pregnant or had a hysterectomy with removal of the cervix, previous screening less than 5 years, or treatment of the cervix or had symptoms of potential cervical cancer were excluded.

Interventions

A community-based hrHPV self-collected screening for cervical cancer was conducted from June 2022 to July 2023.

Main outcome measures

Prevalence of cervical hrHPV and risk factor association.

Results

11 127 women were eligible for screening; 7850 women submitted hrHPV self-swabs, 7828 valid HPV test results were reported and 164 women (2.1%) tested hrHPV positive. Women living in the North were 2.1 times more likely to be hrHPV positive compared with women living in the South (adjusted OR (AOR)=2.1, 95% CI: 1.5 to 3.8, p=0.023) and widowed women were 3.0 times more likely to be hrHPV positive than married women (AOR=3.0, 95% CI: 1.7 to 5.3, p=0.001). Another risk factor associated with testing hrHPV positive was the use of hormonal contraceptives for 5 years and above (AOR=7.0, 95% CI: 2.0 to 24.4, p=0.002).

Conclusion

The study identified a low overall prevalence of hrHPV infection (2.1%) among women in hard-to-reach areas in Bangladesh, with some regional variations. Higher prevalence was observed in widowed compared with married women and among women reporting more than 5 years of hormonal contraceptive use. This study shows no evidence of particularly high-risk groups in hard-to-reach areas in Bangladesh. The findings support the feasibility of implementing a nationwide hr-HPV-based self-sampling strategy as a viable approach to reach WHO targets for reducing the burden of cervical cancer. Recommendation for policymakers to support future research to identify hrHPV prevalence among women in comparable groups in other geographically remote areas in Bangladesh.

Trial registration number

NCT05234112.

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