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Open Access Study Protocol Issue
Rationale and Trial Design of DAWNA‐FES Trial: Single‐Arm Phase Ⅱ Study of Endocrine Therapy With Dalpiciclib After Progression on CDK4/6 Inhibition Based on [18F]FES PET/CT in Patients With HR+/HER2− Advanced Breast Cancer
Cancer Innovation 2026, 5(3): e70058
Published: 30 April 2026
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Background

Cyclin‐dependent kinase 4/6 (CDK4/6) inhibitors have become a cornerstone in the first‐line management of hormone receptor‐positive, human epidermal growth factor receptor 2‐negative (HR+/HER2−) advanced breast cancer. Despite their clinical efficacy, most patients eventually experience disease progression, and optimal treatment strategies following CDK4/6 inhibitor resistance remain unclear. Emerging evidence suggests that switching endocrine therapy (ET) while continuing cyclin inhibition may provide additional clinical benefit. Dalpiciclib, a selective CDK4/6 inhibitor, in combination with physician‐selected ET, represents a potential option in this setting. Concurrently, 16α‐[18F]fluoro‐17β‐estradiol ([18F]FES) PET/CT, a novel imaging modality targeting estrogen receptors (ER), enables non‐invasive, whole‐body assessment of ER expression in metastatic lesions, offering a personalized approach to treatment selection.

Methods

This is a prospective, single‐center, single‐arm Phase Ⅱ clinical trial evaluating the efficacy and safety of dalpiciclib plus ET in HR+/HER2− advanced breast cancer patients who progressed on prior CDK4/6 inhibitor therapy. Forty eligible patients with confirmed metastases and at least one [18F]FES‐positive lesion will be enrolled. Participants will receive dalpiciclib combined with ET as determined by the treating physician. The primary endpoint is progression‐free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), and overall survival (OS).

Discussion

Beyond evaluating efficacy, this single‐center phase Ⅱ trial will provide practical insight into the feasibility of [18F]FES PET/CT‐guided patient selection, including standardized imaging workflows and multidisciplinary implementation in routine clinical research. Positive outcomes may support a personalized, imaging‐guided strategy to prolong disease control after prior CDK4/6 inhibitor progression.

Ethical Approval and Trial Registration

Approved by the Ethics Committee of Peking Union Medical College Hospital (Approval number: K3629); registered at ClinicalTrials. gov (NCT05613270).

Issue
Novel 18F-FES PET/CT in Non-invasive Functional Diagnosis of Delayed Lung Metastasis Presented with Horner Syndrome in a Metastatic Breast Cancer Patient
Medical Journal of Peking Union Medical College Hospital 2024, 15(3): 702-707
Published: 30 May 2024
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Hormonal receptor positive human epidermal receptor 2 negative (HR+/HER2-) is the commonest molecular subtype of breast cancer (BC). Patients with HR+/HER2- BC may manifest clinically a late recurrence whose BC metastasizes 10-15 years post-operatively. We report one case who presented with pulmonary mass in upper lobe of lung and Horner syndrome 16 years after BC surgery. FDG PET/CT suggested pulmonary malignancy but could not differentiate between primary or metastatic cancer when invasive biopsy was quite risky. Novel 18F-FES PET/CT facilitated the non-invasive functional diagnosis of estrogen-receptor positive (ER+) pulmonary metastasis of BC, and the patient experienced partial response (PR) after CDK4/6 inhibitor and aromatase inhibitor as endocrine therapy. This article reviews the diagnosis and treatment process of this case, to provide guidance for non-invasive global evaluation of ER status among metastatic HR+/HER2- BC patients with 18F-FES PET/CT.

Issue
Evaluation of Von Hippel-Lindau Syndrome Through Novel Small Molecular Tracer 68Ga-NY104 PET/CT Imaging
Medical Journal of Peking Union Medical College Hospital 2024, 15(4): 911-915
Published: 30 July 2024
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VHL (von Hipple-Lindau) syndrome is a rare autosomal dominant genetic disease with complex and diverse clinical manifestations, which primarily presents as multiple tumors in the retina, central nervous system, kidneys, pancreas, and other areas. Patients often require comprehensive multi-organ assessment. Carbonic anhydrase Ⅸ (CAⅨ) is ubiquitously expressed in VHL-related lesions, and 68Ga-NY104, a novel small-molecule tracer, can perform whole-body imaging of CAⅨ-positive lesions. This case report introduces a 32-year-old female patient with VHL syndrome who underwent sequential 18F-FDG PET/CT and 68Ga-NY104 PET/CT for lesion assessment. Notably, 68Ga-NY104 PET/CT demonstrated uptake in a broader range of lesions (including renal, pancreatic, hepatic metastatic lesions and cerebellar lesions). This article discusses the process of evaluating the relevant lesions in this patient, with the aim of exploring a "one-stop" evaluation tool for patients with VHL syndrome.

Issue
Principles and Clinical Applications of Boron Neutron Capture Therapy
Medical Journal of Peking Union Medical College Hospital 2023, 14(4): 698-705
Published: 04 April 2023
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Boron neutron capture therapy (BNCT) is an advanced radiation therapy technique that is rapidly developing in the field of cancer treatment. This technique, an atomic-level binary targeted therapy, kills cancer cells by causing a 10B(n, α)7Li nuclear reaction within the cancer cells, and its clinical implementation requires professional technology and device support. The core elements of BNCT include appropriate neutron sources and neutron capture drugs. Compared with traditional radiotherapy techniques, BNCT shows outstanding advantages in treating locally recurrent tumors, such as central nervous system tumors and head and neck tumors. Furthermore, it can better protect normal organs, especially for tumors that have already significantly invaded surrounding organs, demonstrating its promising future prospects. This article mainly elaborates on the technical principles, core elements, and clinical applications of BNCT, in hope of providing reference for clinical diagnosis and treatment.

Open Access Issue
A Chan-Vese Model Based on the Markov Chain for Unsupervised Medical Image Segmentation
Tsinghua Science and Technology 2021, 26(6): 833-844
Published: 09 June 2021
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The accurate segmentation of medical images is crucial to medical care and research; however, many efficient supervised image segmentation methods require sufficient pixel level labels. Such requirement is difficult to meet in practice and even impossible in some cases, e.g., rare Pathoma images. Inspired by traditional unsupervised methods, we propose a novel Chan-Vese model based on the Markov chain for unsupervised medical image segmentation. It combines local information brought by superpixels with the global difference between the target tissue and the background. Based on the Chan-Vese model, we utilize weight maps generated by the Markov chain to model and solve the segmentation problem iteratively using the min-cut algorithm at the superpixel level. Our method exploits abundant boundary and local region information in segmentation and thus can handle images with intensity inhomogeneity and object sparsity. In our method, users gain the power of fine-tuning parameters to achieve satisfactory results for each segmentation. By contrast, the result from deep learning based methods is rigid. The performance of our method is assessed by using four Computerized Tomography (CT) datasets. Experimental results show that the proposed method outperforms traditional unsupervised segmentation techniques.

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