Vulvar Squamous Cell Carcinoma
Conditions
Keywords
Vulvar Squamous Cell Carcinoma, FAPI, Phosphor imaging
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.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of specimens with FAP expression | 10 months | Defines the proportion of VSCC specimens with expression of FAP (%). |
| Quantitative FAP binding | 10 months | Quantitative FAP binding, measured as counts per minute (cpm)/mm2 of residual radioactivity after incubation time/washing step. |
| FAP binding affinity | 10 months | FAP binding affinity, measured as % inhibition of specific binding plotted against the concentration of radiotracers. |
| Distribution of radiotracer in VSCC specimens | 10 months | Distribution of radiotracer in VSCC specimens, measured as cpm/mm2 in specific regions of the specimens (e.g., hypoxic region, perivascular). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 10 months | Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor morphology on hematoxylin and eosin staining (H&E) (adimensional). |
| Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age | 10 months | Probability of testing the correlation of quantitative FAP binding (adimensional) with age (unit: years). |
| Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage | 10 months | Probability of testing the correlation of quantitative FAP binding (adimensional) with tumor FIGO stage (adimensional). |
| Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age | 10 months | Probability of testing the correlation of FAP expression level (unit: digital light unit) with age (unit: years). |
| Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype | 10 months | Probability of testing the correlation of quantitative FAP binding (adimensional) with tumor pathological histotype squamous vs other (adimensional). |
| 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 | 10 months | Probability of testing the correlation of quantitative FAP binding (adimensional) with tumor morphology on hematoxylin and eosin staining (H&E) (adimensional). |
| Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading | 10 months | Probability of testing the correlation of quantitative FAP binding (adimensional) with tumor pathological grading 1-2 vs 3 (adimensional). |
| Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage | 10 months | Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor FIGO stage (adimensional). |
| Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading | 10 months | Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor pathological grading 1-2 vs 3 (adimensional). |
| Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype | 10 months | Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor pathological histotype squamous vs other (adimensional). |
Countries
Italy
Contacts
Primary ContactAngela Collarino, MD, PhD
Outcome results
None listed