Clinical trial · Observational
In Vitro Study of [18F]F-FAPI-74 Feasibility in Vulvar Cancer
NCT06911801CI-TRIAL-00088159FAPI_VULVA_1not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Squamous Cell Carcinoma | Vulvar Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Study cohort
- description
- 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.
Primary outcomes (4)
- measure
- Proportion of specimens with FAP expression
- timeFrame
- 10 months
- description
- Defines the proportion of VSCC specimens with expression of FAP (%).
- measure
- Quantitative FAP binding
- timeFrame
- 10 months
- description
- Quantitative FAP binding, measured as counts per minute (cpm)/mm2 of residual radioactivity after incubation time/washing step.
- measure
- FAP binding affinity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDKlebermass EM, Dengler A, Weissenbock V, Ricken G, Wadsak W, Viernstein H, Hacker M, Mitterhauser M, Philippe C. Autoradiography on deparaffinized tissue sections - A feasibility study with 68Ga-labeled PET-tracers. Appl Radiat Isot. 2022 Nov;189:110425. doi: 10.1016/j.apradiso.2022.110425. Epub 2022 Aug 18. PMID 36030760
- BACKGROUNDKalluri R. The biology and function of fibroblasts in cancer. Nat Rev Cancer. 2016 Aug 23;16(9):582-98. doi: 10.1038/nrc.2016.73. PMID 27550820
- BACKGROUNDLindner T, Giesel FL, Kratochwil C, Serfling SE. Radioligands Targeting Fibroblast Activation Protein (FAP). Cancers (Basel). 2021 Nov 16;13(22):5744. doi: 10.3390/cancers13225744. PMID 34830898
- BACKGROUNDOonk MHM, Planchamp F, Baldwin P, Mahner S, Mirza MR, Fischerova D, Creutzberg CL, Guillot E, Garganese G, Lax S, Redondo A, Sturdza A, Taylor A, Ulrikh E, Vandecaveye V, van der Zee A, Wolber L, Zach D, Zannoni GF, Zapardiel I. European Society of Gynaecological Oncology Guidelines for the Management of Patients with Vulvar Cancer - Update 2023. Int J Gynecol Cancer. 2023 Jul 3;33(7):1023-1043. doi: 10.1136/ijgc-2023-004486. PMID 37369376