Lymph Node MetastasisCANNESNCT05573451
Comparison of the Accuracy of US, MRI and PET/CT in the Assessment of LNs in Cervical Cancer.
An observational study of Lymph Node Metastasis and Cervical Cancer, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
Lymph node involvement is the most important negative prognostic factor in cervical cancer. Reliable preoperative lymph node assessment is of utmost importance to tailor the treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lymph Node Metastasis, Cervical Cancer
- What is being tested?
- ultrasound - transvaginal/transrectal + transabdominal
- How many people
- 91 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Jan 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Tumor type other than primary cervical carcinomas
- Second malignant tumor under treatment
- FIGO stage IV (local spread to rectum or bladder, distant metastases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Lymph node involvement is the most important negative prognostic factor in cervical cancer. Reliable preoperative lymph node assessment is of utmost importance to tailor the treatment. According to the current European guidelines local extent of the disease can be assessed by magnetic resonance imaging (MRI) or by ultrasound (US), if performed by properly trained sonographer. Positron emission tomography combined with computed tomography (PET/CT) is used as a reference standard for preoperative evaluation of lymph nodes. Another technique to assess nodes combining morphological and functional characteristics is diffusion-weighted MRI (DW/MRI). While US is considered the adequate alternative to MRI in local staging of cervical cancer, there is no relevant evidence of diagnostic performace of US in nodal assessment. However, retrospective analysis of diagnostic accuracy of US from our site brought promising results. Furthermore, there are no trials prospectively investigating these three imaging methods in the same study population. The CANNES study is a prospective multicenter trial comparing diagnostic accuracy of US, PET/CT and DW/MRI in preoperative assessment of pelvic lymph nodes in cervical cancer. The study is designed to establish new standard in preoperative assessment of pelvic lymph nodes in patients with cervical cancer. Ninety-one patients will be enrolled into the study within 36 months and each of them will undergo all three imaging methods. To avoid a bias all imaging examinations will be conducted independently and blinded among sonographers, radiologists and nuclear medicine physicians. By contrast, each surgeon will have all reports from imaging available before procedure to be used as a navigation. Surgical procedures will include sentinel lymph node biopsy, debulking/sampling or systematic dissection of pelvic nodes following current European guidelines.
Read the 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.
- Conditions
- Lymph Node Metastasis, Cervical Cancer
- Being tested
- ultrasound - transvaginal/transrectal + transabdominal
- Medical subject headings
- Lymphatic Metastasis, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound - transvaginal/transrectal + transabdominalDiagnostic test
Also called PET-CT (positron emission tomography - computed tomography), DW-MRI (diffusion weighted magnetic resonance imaging)
Each patient undergoes at least ultrasound examination and PET-CT.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is comparison of the overall accuracy of ultrasound, PET/CT and DW/MRI in preoperative detection of pelvic lymph node macrometastases.
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).
Measured: 36 months
Secondary outcomes (2)
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)
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).
Measured: 36 months
Comparison of overall accuracy of US, PET/CT and DW/MRI in assessment of para-aortic lymph node involvement.
Sensitivity, specificity, PPV, NPV, overall acuracy, AUC, LR+, LR- and p-value will be calculated for each imaging method per patient.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start20 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Principal investigator, Filip Fruhauf, General University Hospital, Prague
- Investigators
- Filip Fruhauf, Principal investigator, General University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573451
- Sponsor's protocol ID
- NU21-03-00461
- Acronym
- CANNES
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05573451
- Acronym / sponsor ID
- CANNES / NU21-03-00461
- Conditions
- Lymph Node Metastasis, Cervical Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lymph node involvement is the most important negative prognostic factor in cervical cancer. Reliable preoperative lymph node assessment is of utmost importance to tailor the treatment. According to the current European guidelines local extent of the disease can be assessed by magnetic resonance imaging (MRI) or by ultrasound (US), if performed by properly trained sonographer. Positron emission tomography combined with computed tomography (PET/CT) is used as a reference standard for preoperative evaluation of lymph nodes. Another technique to assess nodes combining morphological and functional characteristics is diffusion-weighted MRI (DW/MRI). While US is considered the adequate alternative to MRI in local staging of cervical cancer, there is no relevant evidence of diagnostic performace of US in nodal assessment. However, retrospective analysis of diagnostic accuracy of US from our site brought promising results. Furthermore, there are no trials prospectively investigating these three imaging methods in the same study population. The CANNES study is a prospective multicenter trial comparing diagnostic accuracy of US, PET/CT and DW/MRI in preoperative assessment of pelvic lymph nodes in cervical cancer. The study is designed to establish new standard in preoperative assessment of pelvic lymph nodes in patients with cervical cancer. Ninety-one patients will be enrolled into the study within 36 months and each of them will undergo all three imaging methods. To avoid a bias all imaging examinations will be conducted independently and blinded among sonographers, radiologists and nuclear medicine physicians. By contrast, each surgeon will have all reports from imaging available before procedure to be used as a navigation. Surgical procedures will include sentinel lymph node biopsy, debulking/sampling or systematic dissection of pelvic nodes following current European guidelines.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Tumor type other than primary cervical carcinomas
- Second malignant tumor under treatment
- FIGO stage IV (local spread to rectum or bladder, distant metastases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound - transvaginal/transrectal + transabdominalAlso: PET-CT (positron emission tomography - computed tomography), DW-MRI (diffusion weighted magnetic resonance imaging)Each patient undergoes at least ultrasound examination and PET-CT. | Diagnostic test | – |
Primary outcome
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).
2 secondary outcomes
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
Comparison of overall accuracy of US, PET/CT and DW/MRI in assessment of para-aortic lymph node involvement.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Fruhauf principal investigator
General University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymph Node Metastasis and Cervical Cancer, run by General University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.