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

NCT06911801NOT_YET_RECRUITINGOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

Start Date

2025-04-01

Completion Date

2026-01-01

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Vulvar Squamous Cell Carcinoma

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Proportion of specimens with FAP expression

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

Time frame: 10 months

Quantitative FAP binding

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

Time frame: 10 months

FAP binding affinity

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

Time frame: 10 months

Distribution of radiotracer in VSCC specimens

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

Time frame: 10 months

Secondary Outcomes

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

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

Time frame: 10 months

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

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

Time frame: 10 months

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

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

Time frame: 10 months

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

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

Time frame: 10 months

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

Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor morphology on hematoxylin and eosin staining (H\&E) (adimensional).

Time frame: 10 months

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

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

Time frame: 10 months

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

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

Time frame: 10 months

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

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

Time frame: 10 months

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

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

Time frame: 10 months

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

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

Time frame: 10 months

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy

Linked Papers

2023-07-03

European Society of Gynaecological Oncology Guidelines for the Management of Patients with Vulvar Cancer - Update 2023

As part of its mission to improve the quality of care for women with gynecological cancers across Europe, the European Society of Gynaecological Oncology (ESGO) first published in 2017 evidence-based guidelines for the management of patients with vulvar cancer. To update the ESGO guidelines based on the new evidence addressing the management of vulvar cancer and to cover new topics in order to provide comprehensive guidelines on all relevant issues of diagnosis and treatment of vulvar cancer. The ESGO Council nominated an international development group comprised of practicing clinicians who provide care to vulvar cancer patients and have demonstrated leadership through their expertize in clinical care and research, national and international engagement and profile as well as dedication to the topics addressed to serve on the expert panel (18 experts across Europe). To ensure that the statements were evidence-based, new data identified from a systematic search were reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Prior to publication, the guidelines were reviewed by 206 international practitioners in cancer care delivery and patient representatives. The updated guidelines cover comprehensively diagnosis and referral, staging, pathology, pre-operative investigations, surgical management (local treatment, groin treatment, sentinel lymph node procedure, reconstructive surgery), (chemo)radiotherapy, systemic treatment, treatment of recurrent disease (vulvar, inguinal, pelvic, and distant recurrences), and follow-up. Management algorithms are also defined.

Linked Investigators

Alexandra Taylor

Daniela Fischerova

Elena Ulrikh

François Planchamp

Gian Franco Zannoni

Ignacio Zapardiel

Vincent Vandecaveye