Contribution of PET/MRI in Locally Advanced Cervical Cancer (ATICC)
ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCentre Paul Strauss
About this trial
\[18 F\]fluorodeoxyglucose (18F-FDG) positron emission tomography-magnetic resonance imaging (PET/MRI) is a new hybrid imaging tool that has recently arrived in oncology, and is particularly promising. Its usefulness seems obvious in certain tumor types, but its place in the staging of cervical cancers has never been explored in a prospective trial to our knowledge.
Previously, a comparative retrospective study from 2009 found a better sensitivity of PET fused to diagnostic MRI images compared to PET/CT (positron emission tomography/computed tomography) in the detection of metastatic lymph nodes (54 and 44% respectively). It was an a posteriori fusion of images, from images acquired by PET-CT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged from 18 years old and over
Patients with presumed cervical cancer of stages IB2 to IVA based on clinical data and pelvic MRI, undergoing pre-treatment assessment.
For women of childbearing potential : Adequate contraception throughout study participation.
Disqualifiers
Oncological history that could possibly interfere with imaging results interpretation, apart from cervical cancer
Extra-nodal metastasis clinically or radiologically proven before study participation
Contraindication to MRI or injection of contrast agents containing gadolinium
Contraindication to lumbo-aortic lymphadenectomy
Trial population
Patients with presumed cervical cancer of stages IB2 to IVA based on clinical data and pelvic MRI, undergoing pre-treatment assessment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
18-FDG PET-MRI
Diagnostic testFor this trial, 18-FDG PET-MRI will be conducted directly after PET-CT using a single dose of radiotracer
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Compare performances of PET/MRI and PET/CT in the detection of lumbar aortic lymph node metastases in cervical cancer patients with tumors graded IB2 to IVA stage
Performances in terms of sensitivity
Time frame
Up to 3 monthsSecondary outcomes
1
Compare performances of PET/MRI and PET/CT in the detection of lymph node metastases in cervical cancer patients with tumors graded IB2 to IVA stage, outside of lumbar aortic region
Performances in terms of sensitivity
Time frame
Up to 3 months2
Compare performances PET/MRI and para-aortic lymphadenectomy in the detection of lumbar aortic lymph node metastases in cervical cancer patients
Lumbar/aortic lymph nodes detection with each exams
Time frame
Up to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov