Intraoperative Microscopic Assessment of Lymph Node Status in Gynecological Malignancies

NCT07702721 | Not Yet Recruiting

• 1 other identifier: 26702
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The IMAGINE study is a monocentric, observational, prospective study evaluating the diagnostic performance of Full-Field Optical Coherence Tomography (FF-OCT) combined with Dynamic Cell Imaging (DCI) (Van Gogh System, AQUYRE Biosciences) for the intraoperative detection of lymph node metastases in fresh, unstained, ex vivo specimens from women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer). The primary objective is to assess the sensitivity, specificity, accuracy, negative predictive value, and positive predictive value of FF-OCT/DCI in detecting macrometastases (\>2 mm), micrometastases (\<2 mm), and isolated tumor cells (\<0.2 mm), using hematoxylin-eosin histopathology as the reference standard, with results reported at both the lymph-node and patient level in accordance with STARD guidelines. Secondary objectives include determining the minimum detectable metastatic focus size, developing an FF-OCT/DCI imaging atlas of normal and metastatic lymph nodes, and developing a deep-learning algorithm for automated intraoperative assessment of lymph node status. Based on an estimated 10% prevalence of nodal metastasis, a sample of 351 lymph nodes (approximately 160 patients) will be enrolled - prospectively at Fondazione Policlinico Universitario A. Gemelli IRCCS, and retrospectively from patients previously enrolled in the PROVE study (from February 2026) - over a planned study duration of 36 months.

Conditions

Gynecologic Cancer; Cervical Cancer; Endometrial Cancer; Ovary Cancer; Vulvar Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the sensitivity, specificity, accuracy, negative predictive value and positive predictive value of FF-OCT and DCI in metastasis detection (macro, micro and isolated tumor cells) from lymph nodes.

  sensitivity, specificity, accuracy, negative predictive value and positive predictive value of dynamic cell imaging in detecting lymph nodal metastasis

  3 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women undergoing surgery for gynecological cancers

You may qualify if:

• Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical and vulvar cancer)
• Need for sentinel lymph nodal excision (staging)
• Need for lymph nodal dissection (staging/ cytoreductive reasons)
• years old
• Absence of contemporary lymphatic diseases
• Absence of previous oncological disease in the last 5 years

You may not qualify if:

• Presence of lymphoproliferative or granulomatous diseases affecting lymph nodes
• Active systemic infection or inflammatory conditions influencing lymph node architecture
• Poor-quality lymph node specimens (necrotic, damaged, or with significant optical artifacts)
• Inadequate histopathological reference standard or inability to correlate imaging with histology
• Failure of sentinel lymph node mapping or non-standardized surgical procedures
• Prolonged ischemia time or improper specimen handling prior to imaging (\>30 mins)

Sponsors & Collaborators

• Ministero della Salute, Italy: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Ovarian Neoplasms; Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vulvar Diseases

Study Officials

• Anna Fagotti

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Pavone, MD

CONTACT

0630151; matteopavone.21@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-07