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

April 3, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Angela Collarino, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The specimens of patients with vulvar squamous cell carcinoma, who underwent surgery at the Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, during the study period.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of specimens with FAP expression
Time Frame: 10 months
Defines the proportion of VSCC specimens with expression of FAP (%).
10 months
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.
10 months
FAP binding affinity
Time Frame: 10 months
FAP binding affinity, measured as % inhibition of specific binding plotted against the concentration of radiotracers.
10 months
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).
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 months
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).
10 months
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).
10 months
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).
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
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).
10 months
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).
10 months
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).
10 months
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).
10 months
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 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
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).
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Angela Collarino, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vulvar Squamous Cell Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe