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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 1 trial group
Group A: Study cohort

Trial outcomes

Primary outcomes

1

Proportion of specimens with FAP expression

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

Time frame
10 months
2

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
3

FAP binding affinity

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

Time frame
10 months
4

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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