Breast NeoplasmsNCT04930692
A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
A study testing Contrast-enhanced CT lymphography with the periareolar injection of iopamidol in people with Breast Neoplasms and Sentinel Lymph Node, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Sentinel Lymph Node
- What is being tested?
- Contrast-enhanced CT lymphography with the periareolar injection of iopamidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2022to 1 Aug 2023
- Phase
- Interventional
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years;
- Signed informed consent;
- Histologically confirmed breast cancer
Who cannot join
- Iodine allergy;
- Presence of distant metastases of breast cancer;
- Body mass index more than 40;
- Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
- Suspected pregnancy;
- Severe hypothyroidism;
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- Bronchial asthma in the stage of decompensation;
- Decompensated diabetes;
- Kidney or hepatic failure.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint-Petersburg State University Hospital
Saint Petersburg, 190103
+7(812)676-25-25, 6762525@gosmed.ru
About this study
The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. We also assume that positive predictive value and negative predictive value for identification of presence or absence of metastases in sentinel lymph nodes (SLN) will be high enough for preoperative diagnosis of SLN metastases in breast cancer patients. This study will use CT lymphography with periareolar injection of iopamidol and standard protocols of sentinel lymph nodes biopsy using intraoperative indocyanine green (ICG) fluorescence.
- Conditions
- Breast Neoplasms, Sentinel Lymph Node
- Being tested
- Contrast-enhanced CT lymphography with the periareolar injection of iopamidol
- Keywords
- Breast cancer, Sentinel lymph nodes, CT-Lymphography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced CT lymphography with the periareolar injection of iopamidolDiagnostic test
Patients who meet the inclusion/exclusion criteria will undergo the CT lymphography with periaoreolar injection of a mixture of 4 mL iopamidol and 2 mL of 1% lidocaine hydrochloride. Computed tomographic images will be obtained 1, 3, 5, and 10 minutes after administration of the iopamidol. Following enhancement of the lymphatic duct, the first lymph node to show enhancement will be defined as the SLN.
No later than 10 days after the CT lymphography patients will receive surgical treatment. During breast cancer surgery identification of the SLN using the ICG-fluorescence method with injection of 2 ml indocyanine green into the skin of the areola and the biopsy of identified SLN will be performed. The comparison of the results of CT lymphography and SLN biopsy will be administrated by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative SLNs mapping provided by CT-lymphography method | Experimental | Sentinel lymph nodes will be mapped by contrast-enhanced CT lymphography in breast cancer patients. A mixture of 4 mL iopamidol and 2 mL of 1% lidocaine hydrochloride will be used as a contrast agent provided by periaoreolar injection. No later than 10 days after the CT lymphography patients will receive surgical treatment with sentinel lymph node biopsy using the ICG-fluorescence method. Receives: Diagnostic Test: Contrast-enhanced CT lymphography with the periareolar injection of iopamidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of contrast-enhanced CT lymphography
First primary endpoint is to determine the sensitivity and specificity of contrast-enhanced CT lymphography for the preoperative detection of sentinel lymph nodes in breast cancer in comparison with the intraoperative fluorescence method.
Measured: 8 months
Preoperative detection of sentinel lymph nodes metastases
Second primary endpoint is to assess the capabilities of contrast-enhanced CT lymphography for detecting metastases in sentinel lymph nodes in breast cancer patients
Measured: 8 months
Secondary outcomes (1)
Objective criteria for metastatic lesions of sentinel lymph nodes
Secondary endpoint is to identify objective criteria for metastatic lesions of sentinel lymph nodes (SLN), such as 1) the shape of the lymphatic duct; 2) the contrast enhancement of the SLN (full or heterogeneous); 3) the size of the SLN; 4) the form of the SLN; 5) the density of the SLN.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Oct 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Ahmedov, Saint Petersburg State University, Russia
- Investigators
- Ruslan Ahmedov, MD, Principal investigator, Saint Petersburg State University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930692
- Sponsor's protocol ID
- 03/21
- Status last verified
- Sep 2022
- First submitted
- 10 Jun 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- 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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
- ClinicalTrials.gov ID
- NCT04930692
- Acronym / sponsor ID
- 03/21
- Conditions
- Breast Neoplasms, Sentinel Lymph Node
- Keywords
- Breast cancer, Sentinel lymph nodes, CT-Lymphography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 18 Jun 2021 (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.
The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. We also assume that positive predictive value and negative predictive value for identification of presence or absence of metastases in sentinel lymph nodes (SLN) will be high enough for preoperative diagnosis of SLN metastases in breast cancer patients. This study will use CT lymphography with periareolar injection of iopamidol and standard protocols of sentinel lymph nodes biopsy using intraoperative indocyanine green (ICG) fluorescence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative SLNs mapping provided by CT-lymphography method | Experimental | Diagnostic Test: Contrast-enhanced CT lymphography with the periareolar injection of iopamidolSentinel lymph nodes will be mapped by contrast-enhanced CT lymphography in breast cancer patients. A mixture of 4 mL iopamidol and 2 mL of 1% lidocaine hydrochloride will be used as a contrast agent provided by periaoreolar injection. No later than 10 days after the CT lymphography patients will receive surgical treatment with sentinel lymph node biopsy using the ICG-fluorescence method. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years;
- Signed informed consent;
- Histologically confirmed breast cancer
Key exclusion criteria (9 listed)
- Iodine allergy;
- Presence of distant metastases of breast cancer;
- Body mass index more than 40;
- Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
- Suspected pregnancy;
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 |
|---|---|---|
| Contrast-enhanced CT lymphography with the periareolar injection of iopamidolPatients who meet the inclusion/exclusion criteria will undergo the CT lymphography with periaoreolar injection of a mixture of 4 mL iopamidol and 2 mL of 1% lidocaine hydrochloride. Computed tomographic images will be obtained 1, 3, 5, and 10 minutes after administration of the iopamidol. Following enhancement of the lymphatic duct, the first lymph node to show enhancement will be defined as the SLN. No later than 10 days after the CT lymphography patients will receive surgical treatment. During breast cancer surgery identification of the SLN using the ICG-fluorescence method with injection of 2 ml indocyanine green into the skin of the areola and the biopsy of identified SLN will be performed. The comparison of the results of CT lymphography and SLN biopsy will be administrated by the investigator. | Diagnostic test | Preoperative SLNs mapping provided by CT-lymphography method |
Primary outcome
Sensitivity and specificity of contrast-enhanced CT lymphography
Time frame: 8 months
First primary endpoint is to determine the sensitivity and specificity of contrast-enhanced CT lymphography for the preoperative detection of sentinel lymph nodes in breast cancer in comparison with the intraoperative fluorescence method.
Preoperative detection of sentinel lymph nodes metastases
Time frame: 8 months
Second primary endpoint is to assess the capabilities of contrast-enhanced CT lymphography for detecting metastases in sentinel lymph nodes in breast cancer patients
1 secondary outcome
Objective criteria for metastatic lesions of sentinel lymph nodes
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- 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.
Ruslan Ahmedov, MD principal investigator
Saint Petersburg State University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced CT lymphography with the periareolar injection of iopamidol in people with Breast Neoplasms and Sentinel Lymph Node, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 3 inclusion and 9 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 6 Sep 2022. 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 Russia. 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?
Contact Valeria Konstantinova, MD (+79315352637, konstantinova.valery@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of contrast-enhanced CT lymphography (time frame: 8 months). The study lists 2 primary outcomes in all. 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 6 Sep 2022.