Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer

NCT ID: NCT04008095

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-08

Study Completion Date

2026-01-08

Brief Summary

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A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT in the management of uterine cervical cancer. Post therapy 18F-FDG PET/CT is usually requested by a lot of clinicians.

Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.

This prospective multicenter observational study will evaluate the interest of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with cervical cancer at an advanced stage.

Main outcome :

The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.

Investigators will compare :

* decision of clinicians without 18F-FDG PET/CT results
* and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.

Detailed Description

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With approximately 3000 new cases estimated in France on 2017, the uterine cervical cancer is the twelfth cancer cause in women, responsible for 1000 deaths per year.

Management of uterine cervical cancer is well defined before treatment, especially for imaging including systematically pelvic MRI and 18F-FDG PET/CT.

A lot of studies have demonstrated the prognostic value of post therapy 18F-FDG PET/CT, due to semi quantitative parameters study, like the SUV max and delta SUV between pre and post therapy 18F-FDG PET/CT or qualitatively with the persistence of positive 18F-FDG PET/CT at the end of therapy.

Whereas 18F-FDG PET/CT is useful for prognosis in the follow-up, data are yet insufficient to clearly establish a formal recommendation.

Nevertheless, post therapy 18F-FDG PET/CT is still usually requested by a lot of clinicians.

Furthermore, the group of Parisian public hospital (AP-HP) has established a guide for the management of cervical cancer (2016) and recommends to systematically realize a 18F-FDG PET/CT after treatment for advanced cervical cancer.

Main purpose :

Evaluate the role of post therapy 18F-FDG PET/CT in clinical management (within 2 months of treatment) in patients with uterine cervical cancer at an advanced stage.

Main outcome :

The therapeutic impact of post therapy 18F-FDG PET/CT (within 2 months after the end of therapy) will be evaluated on the complete results included MRI.

Investigators will compare

* decision of clinicians without 18F-FDG PET/CT results
* and decision of clinicians knowing entire results included results of 18F-FDG PET/CT.

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient old ≥ 18 years
* Uterine cervical cancer with locally-advanced (FIGO 2019 IB3 to IVA)
* Histology: squamous cell carcinoma and adenocarcinoma
* Feasibility of a curative treatment
* Having formulated a non-opposition

Exclusion Criteria

* Minor patient \< 18 years
* Pregnancy or breastfeeding
* Other type of tumor than squamous cell carcinoma and adenocarcinoma
* FIGO 2019 \< IB3 or \> IVA
* Non-eligibility for the examination
* Contraindication to MRI and PET/CT
* Previous history of cancer
* Refusal of participation
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest (Hôpital Morvan)

Brest, , France

Site Status RECRUITING

Centre Henri Becquerel

Rouen, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Alexandra LE DUC-PENNEC

Role: CONTACT

+33 2 98 22 31 19

Facility Contacts

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Alexandra LE DUC-PENNEC

Role: primary

+332 98 22 3119

Agathe EDET-SANSON

Role: primary

+33 2 32 08 25 50

Other Identifiers

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29BRC19.0084

Identifier Type: -

Identifier Source: org_study_id

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