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

Cervical Cancer Clinical Trial

— COLTEP  

Official title:

Evaluation of the Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer at an Advanced Stage. Multicenter Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04008095
• Other study ID #: 29BRC19.0084
• Status: Recruiting
• Start date: January 8, 2020
• Est. completion date: January 8, 2026

Study information

• Verified date: April 2023
• Source: University Hospital, Brest
• Contact: Alexandra LE DUC-PENNEC
• Phone: +33 2 98 22 31 19
• Email: alexandra.leduc-pennec[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 8, 2026
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
France	CHRU de Brest (Hôpital Morvan)	Brest
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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: Complete therapeutic response; Equivocal response: doubt about the presence of residual disease.; 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	Physiological analysis parameter	Diagnostic performances of PET/CT, Sensibility, Specificity, positive predictive value, negative predictive value	24 months follow up
Secondary	Prognostic factors	Especially dynamic parameters (SUV max ...) and search for a statistical correlation between this value and PFS and OS.	24 months follow up
Secondary	Physiological analysis, hotspots study	Hotspots study - Search for a density intersection between the local site residual disease of post-therapeutic 18F-FDG PET/CT and maximum-fixing tumor sites in 18F-FDG PET/CT Baseline.	24 months follow up
Secondary	Physiological analysis, hotspots study	Hotspots study - Search maximum-fixing tumor sites in 18F-FDG PET/CT Baseline	24 months follow up
Secondary	Physiological analysis, hotspots study	Assess the dosimetry of an escalation of the dose on these hotspots.	24 months follow up