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Clinical Trials in Italy / NCT06911801
Starting soon Observational

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

NCT06911801 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2025-04
Last updated
2025-04-04

Condition(s) studied

Vulvar Squamous Cell Carcinoma

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome RM

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06911801 on ClinicalTrials.gov ↗ ← All trials in Italy