Magnetic Resonance Fingerprinting for Preoperative Evalua... | NCT05808933

Studies
Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer

NCT05808933

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Recruiting

Last Update Posted

Apr 12, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Cervical Cancer

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2022Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Mar 6, 2023

First Submission Date that Met QC Criteria

Mar 29, 2023

First Posted Date

Apr 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2023

Last Update Posted Date

Apr 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this observational prospective study is to investigate the role of Magnetic Resonance Fingerprinting in preoperative assessment of early cervical cancer

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association between T1-, T2- and ADC-maps and LVSI status		3 months

Secondary Outcomes

Measure	Description	Time Frame
Correlation between T1-, T2- and ADC-maps and DFS and OS		3 years
Correlation between Radiomics-based analysis and LVSI status and DFS and OS		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with biopsy-proven cervical cancer FIGO stage IA-IIA undergoing surgery;
Women aged >18 years old;
Signed Informed Consent.

Exclusion Criteria:

Concurrent malignancies at other sites;
Previous history of neoplasm;
Refusal to sign written informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of cervical cancer (FIGO IA-IIA) that will undergo to surgery at Fondazione Policlinico Universitario "A. Gemelli" IRCCS can be included in this study, according to inclusion and exclusion criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benedetta B Gui, MD	Contact	0630155464	+39	benedetta.gui@policlinicogemelli.it
Luca L Russo, MD	Contact	0630156054	+39	luca.russo@guest.policlinicogemelli.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitaro "A. Gemelli" IRCCS	Recruiting	Roma		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided