Endometrial CancerMARF-ENCT05807672
Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer
An observational study of Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In this context, the aim of this study is to investigate the role of MRF in endometrial cancer. Several applications are possible. Firstly, T1-, T2- and DWI-mappings can be associated to molecular risk group classification, in order to stratify patients' risk without recurring to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 23 Apr 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients that undergo to clinics/hospitalization examination at Fondazione Policlinico Universitario "A. Gemelli" IRCCS for endometrial cancers will be candidate to partecipate to this study, according to exclusion and inclusion criteria.
Who may be able to join
- Patients with biopsy-proven endometrial cancer;
- Women aged > 18 years old;
- Signed Informed consent.
Who cannot join
- Previous history of neoplasm;
- Concurrent malignancies at other sites.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Roma, 00168
Benedetta B Gui, MD, 0630156054 ext. +39, benedetta.gui@policlinicogemelli.it
About this study
Official title: MARF-E- Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer
In this context, the aim of this study is to investigate the role of MRF in endometrial cancer. Several applications are possible. Firstly, T1-, T2- and DWI-mappings can be associated to molecular risk group classification, in order to stratify patients' risk without recurring to surgery. MRF parameters can be also correlated to prognosis, both in terms of disease-free survival (DFS) and overall survival (OS).
- Conditions
- Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between T1-, T2- and diffusion-mappings and risk group classification
Measured: 3 months
Secondary outcomes (4)
Diagnostic accuracy of T1-,T2- and diffusion-mappings deriving from MRF in myometrial invasion detection
Measured: 3 months
Correlation between T1-, T2- and diffusion mappings and DFS and OS
Measured: 3 years
Diagnostic accuracy of T1-,T2- and diffusion-mappings and pathological nodal involvement
Measured: 3 months
Evaluation of Radiomic and Radiogenomic models to predict recurrence in early stage EC and to predict DFS and OS
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start23 Apr 2022
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807672
- Sponsor's protocol ID
- 4690
- Acronym
- MARF-E
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MARF-E- Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05807672
- Acronym / sponsor ID
- MARF-E / 4690
- Conditions
- Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 23 Apr 2022 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this context, the aim of this study is to investigate the role of MRF in endometrial cancer. Several applications are possible. Firstly, T1-, T2- and DWI-mappings can be associated to molecular risk group classification, in order to stratify patients' risk without recurring to surgery. MRF parameters can be also correlated to prognosis, both in terms of disease-free survival (DFS) and overall survival (OS).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that undergo to clinics/hospitalization examination at Fondazione Policlinico Universitario "A. Gemelli" IRCCS for endometrial cancers will be candidate to partecipate to this study, according to exclusion and inclusion criteria.
Key inclusion criteria (3 listed)
- Patients with biopsy-proven endometrial cancer;
- Women aged > 18 years old;
- Signed Informed consent.
Key exclusion criteria (2 listed)
- Previous history of neoplasm;
- Concurrent malignancies at other sites.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between T1-, T2- and diffusion-mappings and risk group classification
Time frame: 3 months
4 secondary outcomes
Diagnostic accuracy of T1-,T2- and diffusion-mappings deriving from MRF in myometrial invasion detection
Time frame: 3 months
Correlation between T1-, T2- and diffusion mappings and DFS and OS
Time frame: 3 years
Diagnostic accuracy of T1-,T2- and diffusion-mappings and pathological nodal involvement
Time frame: 3 months
Evaluation of Radiomic and Radiogenomic models to predict recurrence in early stage EC and to predict DFS and OS
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedetta B Gui, MD (+39 0630156054 ext. +39, benedetta.gui@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between T1-, T2- and diffusion-mappings and risk group classification (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.