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

NCT04008095 | Completed

• 1 other identifier: 29BRC19.0084
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

cervical cancer; pet/ct; post-therapeutic; advanced stage; management

Outcome Measures

Primary Outcomes (2)

• 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. Gold Standard for the diagnosis of progression will be based on the conclusions of multi-disciplinary staff ruling on the results of composite data, including clinical examination, biology, histopathology, morphological imaging (MRI), functional imaging (PET/CT) and 6-month follow-up.

  Validated by six months follow up

• collection of the two décisions of RCP

  To make statistical analysis possible, the collection of the two decisions will be chosen from three cases of care envisaged below: 1. Complete therapeutic response 2. Equivocal response: doubt about the presence of residual disease. 3. Strong suspicion of residual disease and/or progression Then, we will collect a percentage of patients with rightly changes on management induced by the result of the PET-CT at 18F-FDG.

  Validated by six months follow up

Secondary Outcomes (5)

• Physiological analysis parameter

  24 months follow up

• Prognostic factors

  24 months follow up

• Physiological analysis, hotspots study

  24 months follow up

• Physiological analysis, hotspots study

  24 months follow up

• Physiological analysis, hotspots study

  24 months follow up

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women recently diagnosed for an advanced cervical cancer (FIGO 2019 IB3 to IVA), and histologically proved.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHRU de Brest (Hôpital Morvan)

Brest, 29200, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: July 5, 2019
• Study Start: January 8, 2020
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data accesss agreement

Locations

FR (2)