- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05573451
Comparison of the Accuracy of US, MRI and PET/CT in the Assessment of LNs in Cervical Cancer. (CANNES)
CANNES (Cervical Cancer Lymph Node Staging): A Prospective, Imaging Study to Compare the Diagnostic Accuracy of Ultrasound, MRI and PET/CT in the Preoperative Assessment of Lymph Nodes in Cervical Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
CANNES is a single arm, multicenter, prospective imaging trial. Patients referred with histopathologically confirmed cervical cancer will be clinically examined. As standard of care one of imaging method will be performed in preoperative local work-up - ultrasound or DW/MRI. The preference of imaging method of the first choice depends on the institutional practice. Eligible women meeting all inclusion criteria will be provided with the following documents ("Informed consent" and "Information for patients") and the objectives and the course of the study will be discussed with them. After the written consent, patients will be registered into the database using REDCap (Research Electronic Data Capture, www.project-redcap.org) electronic data capture tool. It is a secure, web-based application with controlled access designed to support data capture for research studies, hosted at MD Anderson.
To avoid any bias all imaging examinations will be conducted independently and blinded among sonographers, radologists and nuclear medicine physicians, i.e. without access to the reports from other examinations. In situation that sonographer is gynecologic oncologist, she/he will never perform and report ultrasound and surgery of the same patient. The same radiologist will never report the PET/CT and DW/MRI of the same patient. Examinators performing ultrasound scan and radiologists performing PET/CT or DW/MRI will be well instructed about standardized approach and evaluation of the imaging will follow predefined protocols. If a patient already had PET/CT or DW/MRI done by the referring hospital, the study radiologists decide about the quality of imaging and necessity to repeat them. All scans must be assessed by the radiologists involved in the study. Similarly, ultrasound examination will be only performed by expert sonographers participating in the trial. For every examination, a separate evaluation form (US form, PET/CT form and DW/MRI form) containing only the information of this examination will be used.
Surgery (laparoscopy, laparotomy or robotic surgery) should always be performed within 6 weeks after the first imaging method. Surgical procedure must include SLNB or sampling/debulking of suspicious/enlarged pelvic lymph nodes (± inframesenteric PALND) or systematic PLND. Surgeons will have all reports from ultrasound, PET/CT and DW/MRI available before surgery to be used as a navigation. All radiologically positive lymph nodes must be removed. Surgery evaluation form with precise description of the intraoperative finding will be filled in. Five evaluation forms will be completed (clinical data, US, PET/CT, DW/MRI, surgery) immediately when procedure finished using electronic database. The sixth evaluation form (pathology) will be completed when available by principal investigator.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Filip Fruhauf
- Phone Number: +420224967451
- Email: filip.fruhauf@vfn.cz
Study Contact Backup
- Name: Daniela Fischerova
- Phone Number: +420224967451
- Email: daniela.fischerova@vfn.cz
Study Locations
-
-
-
Prague, Czechia
- Recruiting
- General University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients with histopathologically confirmed cervical cancer will be clinically examined. As standard of care one of imaging method will be performed in preoperative local work-up - ultrasound or DW/MRI. Per protocol PET/CT will be added.
Surgery (laparoscopy, laparotomy or robotic surgery) should always be performed within 6 weeks after the first imaging method. Surgical procedure must include SLNB or sampling/debulking of suspicious/enlarged pelvic lymph nodes (± inframesenteric PALND) or systematic PLND. Surgeons will have all reports from ultrasound, PET/CT and DW/MRI available before surgery to be used as a navigation.
Description
Inclusion Criteria:
- Histopathologically verified cervical cancer
- FIGO stage IA1 L1 (lymphovascular space involvement) - IIIC2
- Patient eligible for surgery (PLND, sampling or debulking of LNs, SLNB)
- PET/CT scan not contraindicated
- 18 > Age < 80
- Eastern Cooperative Oncology Group (ECOG) performance status grade < 3
- Non-pregnant patient
- Informed consent signed
Exclusion Criteria:
- Tumor type other than primary cervical carcinomas
- Second malignant tumor under treatment
- FIGO stage IV (local spread to rectum or bladder, distant metastases)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary endpoint is comparison of the overall accuracy of ultrasound, PET/CT and DW/MRI in preoperative detection of pelvic lymph node macrometastases.
Time Frame: 36 months
|
Sensitivity, specificity, PPV, NPV, overall acuracy, AUC, LR+, LR- and p-value will be calculated for each imaging method per patient and per site (separately right and left pelvic lymph nodes).
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of overall accuracy of US, PET/CT and DW/MRI in detection of pelvic lymph node involvement according to the TNM and FIGO classification (including both macrometastases and micrometastases)
Time Frame: 36 months
|
Sensitivity, specificity, PPV, NPV, overall acuracy, AUC, LR+, LR- and p-value will be calculated for each imaging method per patient and per site (separately right and left pelvic lymph nodes).
|
36 months
|
Comparison of overall accuracy of US, PET/CT and DW/MRI in assessment of para-aortic lymph node involvement.
Time Frame: 36 months
|
Sensitivity, specificity, PPV, NPV, overall acuracy, AUC, LR+, LR- and p-value will be calculated for each imaging method per patient.
|
36 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Filip Fruhauf, General University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU21-03-00461
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on ultrasound - transvaginal/transrectal + transabdominal
-
Cairo UniversityCompletedTrans Abdominal Ultrasound | Transvaginal Ultrasound | Lower Uterine Segment ThicknessEgypt
-
Hadassah Medical OrganizationUnknownIn Vitro FertilizationIsrael
-
Menoufia UniversityAlexandria UniversityCompleted
-
University of FlorenceUnknown
-
Ain Shams UniversityCompletedDiagnoses Disease | Genital Diseases, Female | VirginityEgypt
-
Kasr El Aini HospitalCompleted
-
Cairo UniversityUnknown
-
David BleharCompleted
-
Columbia UniversityCompletedAbortion EarlyUnited States
-
Line ModinUniversity of Southern DenmarkCompleted