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

NCT06911801 | Not Yet Recruiting

• 1 other identifier: 7284
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vulvar Squamous Cell Carcinoma

Keywords

Vulvar Squamous Cell Carcinoma; FAPI; Phosphor imaging

Outcome Measures

Primary Outcomes (4)

• Proportion of specimens with FAP expression

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

  10 months

• Quantitative FAP binding

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

  10 months

• FAP binding affinity

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

  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).

  10 months

Secondary Outcomes (10)

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

  10 months

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

  10 months

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

  10 months

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

  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

  10 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Coexistence of primary tumours other than vulvar cancer

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, 00168, Italy

Location

Related Publications (4)

• Klebermass 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 BACKGROUND

• Kalluri 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 BACKGROUND

• Lindner 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 BACKGROUND

• Oonk 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Vulvar squamous cell carcinoma specimens obtained from surgical biopsies, stored in optimal cutting temperature compound and formalin-fixed paraffin-embedded.

Study Officials

• Angela Collarino, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Collarino, MD, PhD

CONTACT

0039 06 3015 6157; angela.collarino@policlinicogemell.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)