In Vitro Study of [18F]F-FAPI-74 Feasibility in Vulvar Cancer (FAPI_VULVA_1)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Vulvar Squamous Cell Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06911801

7284

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 1 patient group

Study cohort

Description:

Tumour specimens stored both in optimal cutting temperature compound and formalin-fixed paraffin-embedded from patients with a first diagnosis of vulvar squamous cell carcinoma. Upon sectioning, the specimens will be analysed using phosphor imaging with FAPI radiopharmaceutical.