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Search / Trial NCT06911801

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 3, 2025

Trial Information

Current as of August 20, 2025

Not yet recruiting

Keywords

Vulvar Squamous Cell Carcinoma Fapi Phosphor Imaging

ClinConnect Summary

This clinical trial is looking to understand how a specific protein, called FAP, is present in samples from women with vulvar squamous cell carcinoma, a type of skin cancer that affects the vulva. The study will use tissue samples taken from patients who have had surgery for this cancer at a hospital in Rome, Italy. Researchers will analyze these samples to see how well the imaging technique works to detect this protein, which could help in understanding and potentially treating vulvar cancer in the future.

To be eligible for this study, participants must be women diagnosed with invasive vulvar squamous cell carcinoma, with samples available from both the main tumor and any affected lymph nodes. It’s important that the samples are stored properly and are large enough for testing. Participants will not need to do anything extra since the study will use existing samples and information already collected during their treatment. Currently, the trial is not yet recruiting participants, so more information will be available as it gets closer to starting.

Gender

FEMALE

Eligibility criteria

  • 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

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, Rm, Italy

Patients applied

0 patients applied

Trial Officials

Angela Collarino, MD, PhD

Principal Investigator

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported