Intraoperative Microscopic Assessment of Lymph Node Status in Gynecological Malignancies

Starting soon

Conditions studied: Gynecologic Cancer, Cervical Cancer, Endometrial Cancer, Ovary Cancer, Vulvar Cancer

In brief

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.

Key facts

Study ID

NCT07702721

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

160

Starts

2026-08-01

Expected to finish

2029-08-01

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

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)
• 18-99 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)

Full record on ClinicalTrials.gov

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