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

NCT ID: NCT06083103

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-12

Study Completion Date

2025-12-31

Brief Summary

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\[18 F\]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.

Detailed Description

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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.

Conditions

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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18-FDG PET-MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Éric OUVRARD, MD

Role: STUDY_CHAIR

Institut de cancérologie Strasbourg Europe

Locations

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Institut de cancérologie Strasbourg Europe

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claire VIT

Role: CONTACT

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

Manon VOEGELIN

Role: CONTACT

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

Facility Contacts

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Éric OUVRARD, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33909101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33894709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31842163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19403303 (View on PubMed)

Other Identifiers

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2023-A00743-42

Identifier Type: OTHER

Identifier Source: secondary_id

2021-013

Identifier Type: -

Identifier Source: org_study_id

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