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NCT Number: NCT06911801

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

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.

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Key information

Conditions

Vulvar Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, 00168, Italy

Location contact

Angela Collarino, MD, PhD

CONTACT

[email protected]

0039 06 3015 6157

Angela Collarino, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of specimens with FAP expression

    Time frame: 10 months

    Defines the proportion of VSCC specimens with expression of FAP (%).

  2. Quantitative FAP binding

    Time frame: 10 months

    Quantitative FAP binding, measured as counts per minute (cpm)/mm2 of residual radioactivity after incubation time/washing step.

  3. FAP binding affinity

    Time frame: 10 months

    FAP binding affinity, measured as % inhibition of specific binding plotted against the concentration of radiotracers.

  4. Distribution of radiotracer in VSCC specimens

    Time frame: 10 months

    Distribution of radiotracer in VSCC specimens, measured as cpm/mm2 in specific regions of the specimens (e.g., hypoxic region, perivascular).

Secondary outcomes

  1. Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age

    Time frame: 10 months

    Probability of testing the correlation of FAP expression level (unit: digital light unit) with age (unit: years).

  2. Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage

    Time frame: 10 months

    Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor FIGO stage (adimensional).

  3. Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading

    Time frame: 10 months

    Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor pathological grading 1-2 vs 3 (adimensional).

  4. Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype

    Time frame: 10 months

    Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor pathological histotype squamous vs other (adimensional).

  5. 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

    Time frame: 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).

  6. Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age

    Time frame: 10 months

    Probability of testing the correlation of quantitative FAP binding (adimensional) with age (unit: years).

  7. Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage

    Time frame: 10 months

    Probability of testing the correlation of quantitative FAP binding (adimensional) with tumor FIGO stage (adimensional).

  8. Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading

    Time frame: 10 months

    Probability of testing the correlation of quantitative FAP binding (adimensional) with tumor pathological grading 1-2 vs 3 (adimensional).

  9. Correlating FAP Binding in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype

    Time frame: 10 months

    Probability of testing the correlation of quantitative FAP binding (adimensional) with tumor pathological histotype squamous vs other (adimensional).

  10. 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

    Time frame: 10 months

    Probability of testing the correlation of quantitative FAP binding (adimensional) with tumor morphology on hematoxylin and eosin staining (H&E) (adimensional).

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Collarino, MD, PhD

CONTACT

[email protected]

0039 06 3015 6157

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: FAPI_VULVA_1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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