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

Cervical Cancer Clinical Trial

— ATICC  

Official title:

Contribution of PET/MRI in Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083103
• Other study ID #: 2021-013
• Secondary ID: 2023-A00743-42
• Status: Recruiting
• Start date: October 12, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Claire VIT
• Phone: (0)3 88 25 85 29
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

[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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

References & Publications (4)

Crimi F, Spolverato G, Lacognata C, Garieri M, Cecchin D, Urso ED, Zucchetta P, Pucciarelli S, Pomerri F. 18F-FDG PET/MRI for Rectal Cancer TNM Restaging After Preoperative Chemoradiotherapy: Initial Experience. Dis Colon Rectum. 2020 Mar;63(3):310-318. doi: 10.1097/DCR.0000000000001568. — View Citation

Kim SK, Choi HJ, Park SY, Lee HY, Seo SS, Yoo CW, Jung DC, Kang S, Cho KS. Additional value of MR/PET fusion compared with PET/CT in the detection of lymph node metastases in cervical cancer patients. Eur J Cancer. 2009 Aug;45(12):2103-9. doi: 10.1016/j.ejca.2009.04.006. Epub 2009 May 4. — View Citation

Lu XR, Qu MM, Zhai YN, Feng W, Gao Y, Lei JQ. Diagnostic role of 18F-FDG PET/MRI in the TNM staging of breast cancer: a systematic review and meta-analysis. Ann Palliat Med. 2021 Apr;10(4):4328-4337. doi: 10.21037/apm-20-2555. Epub 2021 Apr 12. — View Citation

Picardi M, Cavaliere C, Della Pepa R, Nicolai E, Soricelli A, Giordano C, Pugliese N, Rascato MG, Cappuccio I, Campagna G, Cerchione C, Vigliar E, Troncone G, Mascolo M, Franzese M, Castaldo R, Salvatore M, Pane F. PET/MRI for staging patients with Hodgkin lymphoma: equivalent results with PET/CT in a prospective trial. Ann Hematol. 2021 Jun;100(6):1525-1535. doi: 10.1007/s00277-021-04537-5. Epub 2021 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 3 months
Secondary	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	Up to 3 months
Secondary	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	Up to 3 months