Cervical CancerCOLTEPNCT04008095
Interest of PET/CT at 18F-FDG in the Post-therapeutic Management of Cervical Cancer
An observational study of Cervical Cancer, run by University Hospital, Brest at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jan 2020to 5 Feb 2026
- 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: Women recently diagnosed for an advanced cervical cancer (FIGO 2019 IB3 to IVA), and histologically proved.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Brest (Hôpital Morvan)
Brest, 29200
Centre Henri Becquerel
Rouen, 76038
About this study
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
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.
Read more
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.
Read the detailed 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.
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, pet/ct, post-therapeutic, advanced stage, management
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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.
Measured: Validated by six months follow up
Secondary outcomes (5)
Physiological analysis parameter
Diagnostic performances of PET/CT, Sensibility, Specificity, positive predictive value, negative predictive value
Measured: 24 months follow up
Prognostic factors
Especially dynamic parameters (SUV max ...) and search for a statistical correlation between this value and PFS and OS.
Measured: 24 months follow up
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.
Measured: 24 months follow up
Physiological analysis, hotspots study
Hotspots study - Search maximum-fixing tumor sites in 18F-FDG PET/CT Baseline
Measured: 24 months follow up
Physiological analysis, hotspots study
Assess the dosimetry of an escalation of the dose on these hotspots.
Measured: 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start8 Jan 2020
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008095
- Sponsor's protocol ID
- 29BRC19.0084
- Acronym
- COLTEP
- Status last verified
- May 2026
- First submitted
- 31 May 2019
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04008095
- Acronym / sponsor ID
- COLTEP / 29BRC19.0084
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, pet/ct, post-therapeutic, advanced stage, management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 5 Jul 2019 (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.
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
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.
Study design
- Observational model
- Cohort
- 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
- Women recently diagnosed for an advanced cervical cancer (FIGO 2019 IB3 to IVA), and histologically proved.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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
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.
Time frame: Validated by six months follow up
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.
collection of the two décisions of RCP
Time frame: Validated by six months follow up
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.
5 secondary outcomes
Physiological analysis parameter
Time frame: 24 months follow up
Prognostic factors
Time frame: 24 months follow up
Physiological analysis, hotspots study
Time frame: 24 months follow up
Physiological analysis, hotspots study
Time frame: 24 months follow up
Physiological analysis, hotspots study
Time frame: 24 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by University Hospital, Brest at 2 sites in France.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Validated by six months follow up). The study lists 2 primary outcomes in all. 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 20 May 2026.