In Vitro Study of [18F]F-FAPI-74 Feasibility in Vulvar Cancer
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Vulvar Squamous Cell Carcinoma. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study aims to investigate the expression of FAP by phosphor imaging in invasive vulvar squamous cell carcinoma specimens. This in vitro study will include all consecutive tumour specimens stored both in optimal cutting temperature (OCT) compound and formalin-fixed paraffin-embedded (FFPE) from patients with a first diagnosis of vulvar squamous cell carcinoma who underwent surgery at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Подробное описание
Vulvar cancer is a rare gynaecological tumour, affecting 2.5 out of 100,000 women per year. The most common histological type is squamous cell carcinomas. Current guidelines suggest 2-\[18F\]fluoro-2-deoxy-D-glucose (\[18F\]FDG) PET/CT for T2 or larger tumours or when metastases are suspected, even though few studies showed controversial results on small series about the diagnostic accuracy of \[18F\]FDG PET/CT for vulvar cancer. The recently developed fibroblast activation protein inhibitor (FAPI), labelled with gallium-68 or fluorine-18, may be a promising diagnostic tool for gynaecological cancers in the field of PET/CT imaging. There is an unmet need to characterize FAP expression at the whole-body level, to assess target expression for disease detection and FAP-directed therapies. This study aims to investigate the expression of FAP by phosphor imaging in vulvar squamous cell carcinoma specimens on OCT compound and FFPE sections.
Первичные конечные точки
- Proportion of specimens with FAP expression [Срок оценки: 10 months]
- Quantitative FAP binding [Срок оценки: 10 months]
- FAP binding affinity [Срок оценки: 10 months]
- Distribution of radiotracer in VSCC specimens [Срок оценки: 10 months]
Вторичные конечные точки (10)
- Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age [Срок оценки: 10 months]
- Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage [Срок оценки: 10 months]
- Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading [Срок оценки: 10 months]
- Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype [Срок оценки: 10 months]
- Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Morphology on Hematoxylin and Eosin Staining [Срок оценки: 10 months]
- Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age [Срок оценки: 10 months]
- Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage [Срок оценки: 10 months]
- Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading [Срок оценки: 10 months]
- Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype [Срок оценки: 10 months]
- Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Morphology on Hematoxylin and Eosin Staining [Срок оценки: 10 months]
Критерии участия
Критерии включения
- Patients with histologically confirmed diagnosis of invasive vulvar cancer with squamous cell histotype, both from primary tumour site and excised metastatic LNs.
- Availability of both FFPE and OCT stored samples from each primary tumour site and (when available) from the corresponding metastatic groin lymph nodes.
- Samples stored in sufficient quantity not to be completely exhausted by their use for this study.
- Optimal stored sample
- Available clinical and histopathological data
Критерии исключения
\- Coexistence of primary tumours other than vulvar cancer
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
Публикации
- Klebermass EM, Dengler A, Weissenbock V, Ricken G, Wadsak W, Viernstein H, Hacker M, Mitterhauser M, Philippe C. Autoradiography on deparaffinized tissue sections - A feasibility study with 68Ga-labeled PET-tracers. Appl Radiat Isot. 2022 Nov;189:110425. doi: 10.1016/j.apradiso.2022.110425. Epub 2022 Aug 18. PMID 36030760
- Kalluri R. The biology and function of fibroblasts in cancer. Nat Rev Cancer. 2016 Aug 23;16(9):582-98. doi: 10.1038/nrc.2016.73. PMID 27550820
- Lindner T, Giesel FL, Kratochwil C, Serfling SE. Radioligands Targeting Fibroblast Activation Protein (FAP). Cancers (Basel). 2021 Nov 16;13(22):5744. doi: 10.3390/cancers13225744. PMID 34830898
- Oonk MHM, Planchamp F, Baldwin P, Mahner S, Mirza MR, Fischerova D, Creutzberg CL, Guillot E, Garganese G, Lax S, Redondo A, Sturdza A, Taylor A, Ulrikh E, Vandecaveye V, van der Zee A, Wolber L, Zach D, Zannoni GF, Zapardiel I. European Society of Gynaecological Oncology Guidelines for the Management of Patients with Vulvar Cancer - Update 2023. Int J Gynecol Cancer. 2023 Jul 3;33(7):1023-1043. d PMID 37369376
Идентификаторы
NCT: NCT06911801 · 7284