NCT07702721

Not Yet Recruiting

Intraoperative Microscopic Assessment of Lymph Node Status i...

Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source

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Other study identifiers

Sponsor study identifier

26702

Study Type

observational

Estimated enrollment

160

Locations

0 countries

Sites

N/A

Timeline

Study Start

August 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 1, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

August 1, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Estimated enrollment: 160 participants
Study completion date: August 1, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 6, 2026
Actual (reported)
First Posted
July 14, 2026
Actual (reported)
Study Start
August 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 1, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: July 14, 2026
Status Verified: July 2026
Last Update Submitted: July 13, 2026

Conditions

Cervical Cancer Endometrial Cancer Gynecologic 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

Age18 Years - 99 Years

Sexfemale

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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)

Sponsors & Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Otherlead
Ministero della Salute, Italy
Othercollaborator

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsVulvar Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital 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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

August 1, 2029

Estimated

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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)

Contact the study team to confirm eligibility.

Genital Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Vulvar Diseases

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

August 1, 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

July 14, 2026

Record last verified: 2026-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07702721
Data provider: ClinicalTrials.gov
Source updated: 2026-07-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:53 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record