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NCT Number: NCT06083103

Contribution of PET/MRI in Locally Advanced Cervical Cancer (ATICC)

[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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location status: Recruiting

Location contact

Éric OUVRARD, MD

CONTACT

About this study

This monocentric, prospective trial aims at comparing performances of 18F-FDG PET/MRI versus standard PET/CT in the detection of lymph node metastases in cervical cancer patients. Specificity and sensitivity of both exams will be compared at one timepoint, during the PET/CT prescribed in routine care for assessment of extension. PET/MRI will be conducted directly after PET/CT and a unique dose of 18F-FDG radiotracer will be used for both exams.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Note : enrollment in a concomitant clinical trial is authorized

Exclusion criteria

  • 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
  • Persons deprived of liberty
  • Minor or patients placed under guardianship or supervision
  • Patient under judicial protection
  • Patient unable to consent

Treatment and study plan

18-FDG PET-MRI

Diagnostic Test

For this trial, 18-FDG PET-MRI will be conducted directly after PET-CT using a single dose of radiotracer

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

    Time frame: Up to 3 months

    Performances in terms of sensitivity

Secondary 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

    Time frame: Up to 3 months

    Performances in terms of sensitivity

  2. Compare performances PET/MRI and para-aortic lymphadenectomy in the detection of lumbar aortic lymph node metastases in cervical cancer patients

    Time frame: Up to 3 months

    Lumbar/aortic lymph nodes detection with each exams

Study contacts

Contact information is provided by the study sponsor or research team.

Claire VIT

CONTACT

[email protected]

(0)3 88 25 85 29 ext. +33

Manon VOEGELIN

CONTACT

[email protected]

(0)3 68 33 95 23 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Paul Strauss

Other

Registry information

Official study title

Contribution of PET/MRI in Locally Advanced Cervical Cancer

Acronym: ATICC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2023
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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