NCT07702721Not yet recruiting
Intraoperative Microscopic Assessment of Lymph Node Status in Gynecological Malignancies
Intraoperative Microscopic Assessment of Lymph Node Status in Gynecological Malignancies Using Full-Field Optical Coherence Tomography and Dynamic Cell Imaging: A Step From Image Guided Surgery Towards Deep Learning Applications
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Aug 2029
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Endometrial cancer, Cervical cancer, Ovarian cancer
- NCT number
- NCT07702721
What you commit to
- Study type: Observational
- Planned participants: 160
- From 1 Aug 2026 to the primary completion date, 1 Aug 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prolonged ischemia time or improper specimen handling prior to imaging (\>30 mins)
Other illness
- Presence of lymphoproliferative or granulomatous diseases affecting lymph nodes
- Active systemic infection or inflammatory conditions influencing lymph node architecture
- Failure of sentinel lymph node mapping or non-standardized surgical procedures
Other
- Poor-quality lymph node specimens (necrotic, damaged, or with significant optical artifacts)
- Inadequate histopathological reference standard or inability to correlate imaging with histology
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: Female
This page is information, not medical advice. Discuss any trial with your doctor.