Clinical trial NCT06911801: In Vitro Study of [18F]F-FAPI-74 Feasibility in Vulvar Cancer
Official title: In Vitro Study of [18F]F-FAPI-74 Feasibility in Vulvar Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vulvar Squamous Cell Carcinoma
Keywords: Vulvar Squamous Cell Carcinoma
FAPI
Phosphor imaging
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The specimens of patients with vulvar squamous cell carcinoma, who underwent surgery at the Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, during the study period.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Coexistence of primary tumours other than vulvar cancer

Primary outcomes:
measure: Proportion of specimens with FAP expression
timeFrame: 10 months
measure: Quantitative FAP binding
timeFrame: 10 months
measure: FAP binding affinity
timeFrame: 10 months
measure: Distribution of radiotracer in VSCC specimens
timeFrame: 10 months
Secondary outcomes:
measure: Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age
timeFrame: 10 months
measure: Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage
timeFrame: 10 months
measure: Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading
timeFrame: 10 months
measure: Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype
timeFrame: 10 months
measure: 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
timeFrame: 10 months
measure: Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age
timeFrame: 10 months
measure: Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage
timeFrame: 10 months
measure: Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading
timeFrame: 10 months
measure: Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype
timeFrame: 10 months
measure: 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
timeFrame: 10 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Angela Collarino, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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. doi: 10.1136/ijgc-2023-004486.