Sentinel Lymph Node BiopsyNCT05942170
The Combination of Preoperative MRI and SLN in the Surgical Management of CC and EC
A study testing ICG/ blue dye in people with Sentinel Lymph Node Biopsy and MRI, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The aim of the study was to evaluate the diagnostic value of MRI and/or SLN mapping alone or in combination in cervical (CC) and endometrial cancer (EC) patients. Read more about this study
- Who is it for?
- Ages 41 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sentinel Lymph Node Biopsy, MRI
- What is being tested?
- ICG/ blue dye
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 12 Jan 2024
- 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 41 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- histopathological diagnosis of cervical cancer or endometrial cancer
- complete case data
- preoperative MRI examinations completed
- initial treatment is surgical
- all surgeries are entirely staged.
Who cannot join
- patients with suspected extrauterine involvement
- allergic to tracers
- previous history of surgery or radiotherapy to nodal areas
- contraindication for surgical treatment (due to age or comorbidities).
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang, 325000
About this study
Official title: The Combination of Preoperative MRI and Sentinel Lymph Node Biopsy（SLN） in the Surgical Management of Cervical and Endometrial Cancer
The aim of the study was to evaluate the diagnostic value of MRI and/or SLN mapping alone or in combination in cervical (CC) and endometrial cancer (EC) patients.
Read the detailed description
Cervical (CC) and endometrial cancer (EC) are the most common female malignancies after breast cancer. Cervical cancer is one of the three primary malignant tumors of the female reproductive system. According to the 2018 global cancer statistics, Cervical cancer is the 4th most common cancer among women. According to 2020 data there were 16,607 fatal cases and 81,964 new cases of endometrial cancer in China. The presence of pelvic lymph node metastases is the primary poor prognostic marker in the early stages, and the state of para-aortical lymph nodes is an essential predictor of relapse. Compared with patients without lymph node metastasis which get 90-95% five-year survival rates, the patients with pelvic and para-aortic metastatic lymph nodes were only in 50% and 20-30%, respectively.
On the one hand, A previous study reported that pelvic lymph node metastasis was detected in less than 5% of patients with stage IA endometrial cancer but more than 90% of patients with early-stage endometrial cancer underwent unnecessary comprehensive pelvic lymphadenectomy. On the other hand, Lymph nodal status represents a crucial piece of information for the oncologic management of cervical cancer patients. Surgical and pathological diagnosis of lymph nodes is the gold standard for identifying tumor stage of CC and high-risk EC. When lymph nodes metastasis are existed in EC or CC, the treatment approaches may change. A hysterectomy without lymphadenectomy is advised in stage IA1 CC without lymphovascular invasion. It is advised to add a pelvic lymphadenectomy in stages IA2-IB1,and additional adjuvant treatment is recommended once lymph node metastasis is confirmed. The Clinical guidelines of the therapy for high-risk EC is bilateral adnexectomy and radical hysterectomy.Endometrial cancer surgical treatment still remains controversial, particularly when the disease is in its early stages. According to the study, individuals with early-stage endometrial cancer may not receive any therapeutic benefit from a full lymphadenectomy.
However, comprehensive lymphadenectomy has many serious complications including lower extremity lymphedema, pelvic lymphocele, significant bleeding, nerve damage, and postoperative ileus etc. Comprehensive lymphadenectomy may compromise specific healthy lymph nodes' barrier and immunological functions, even to the extent that raising the chance of undetected cancer foci distant metastasizing. Inflammation, tumor size, malignant emboli, compression, physician detection approach, and patient history of neoadjuvant chemotherapy all impact the detection rate and Sensitivity of SLN.
The SLN mapping must have a small proportion of false-negative findings to be considered credible. To put it another way, a pathologically negative SLN must accurately reflect a pathologically negative condition of the ipsilateral pelvis. However, several prospective investigations show that the techniques have weak Sensitivity and a low positive predictive value below a generally recognized criterion of 90%.In this case, a non-invasive strategy has been applied to evaluate the occurrence of lymph node metastases using several imaging modalities. Magnetic resonance imaging (MRI) is the imaging modality used in the initial work-up to study the primary tumor and pelvic lymph node involvement. The use of imaging technologies, such as CT, MRI, PET, and DWI, may enable the accurate detection of pelvic and para-aortic LN metastases in cervical cancer patients as medical science and technology advance. Based on assessments of node size and/or morphologic information, LN metastases have traditionally and widely been detected using MRI.
Aiming to detect early CC and EC patients with lymph node metastases, our study evaluated the Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the preoperative MRI and SLN mapping, alone or in combination, try to find a simpler and safer method for correct diagnosis of lymph node metastasis.
- Conditions
- Sentinel Lymph Node Biopsy, MRI
- Being tested
- ICG/ blue dye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG/ blue dyeDrug
The SLN mapping procedure was performed as previously described by using IGC or blue dye. The injection technique of the tracers was the same for both cervical and endometrial cancer. The cervical injection was done by insulin syringe(one ml) inserting full needle length (1 cm) and complete injection at 3, 9 o'clock, or 2,4,8,10 o'clock.
| Study group | Role | What they receive |
|---|---|---|
| SLN/MRI | Other | Not described Receives: Drug: ICG/ blue dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the preoperative MRI and SLN mapping, alone or in combination
Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The Sensitivity, of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
Measured: 7 days
specificity of the preoperative MRI and SLN mapping, alone or in combination
Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The specificity, of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
Measured: 7 days
positive predictive value (PPV) of the preoperative MRI and SLN mapping, alone or in combination
Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The PPV of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
Measured: 7 days
negative predictive value (NPV) of the preoperative MRI and SLN mapping, alone or in combination
Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The NPV of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Feb 2017
- Primary completion1 Dec 2023 (estimated)
- Study completion12 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph Node BiopsyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- 67 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Zhao, master, Study chair, The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942170
- Sponsor's protocol ID
- SAHoWMU-CR2023-07-101
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Preoperative MRI and Sentinel Lymph Node Biopsy（SLN） in the Surgical Management of Cervical and Endometrial Cancer
- ClinicalTrials.gov ID
- NCT05942170
- Acronym / sponsor ID
- SAHoWMU-CR2023-07-101
- Conditions
- Sentinel Lymph Node Biopsy, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 12 Jan 2024 (estimated)
- First posted
- 12 Jul 2023 (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 aim of the study was to evaluate the diagnostic value of MRI and/or SLN mapping alone or in combination in cervical (CC) and endometrial cancer (EC) patients.
Detailed description
Cervical (CC) and endometrial cancer (EC) are the most common female malignancies after breast cancer. Cervical cancer is one of the three primary malignant tumors of the female reproductive system. According to the 2018 global cancer statistics, Cervical cancer is the 4th most common cancer among women. According to 2020 data there were 16,607 fatal cases and 81,964 new cases of endometrial cancer in China. The presence of pelvic lymph node metastases is the primary poor prognostic marker in the early stages, and the state of para-aortical lymph nodes is an essential predictor of relapse. Compared with patients without lymph node metastasis which get 90-95% five-year survival rates, the patients with pelvic and para-aortic metastatic lymph nodes were only in 50% and 20-30%, respectively.
On the one hand, A previous study reported that pelvic lymph node metastasis was detected in less than 5% of patients with stage IA endometrial cancer but more than 90% of patients with early-stage endometrial cancer underwent unnecessary comprehensive pelvic lymphadenectomy. On the other hand, Lymph nodal status represents a crucial piece of information for the oncologic management of cervical cancer patients. Surgical and pathological diagnosis of lymph nodes is the gold standard for identifying tumor stage of CC and high-risk EC. When lymph nodes metastasis are existed in EC or CC, the treatment approaches may change. A hysterectomy without lymphadenectomy is advised in stage IA1 CC without lymphovascular invasion. It is advised to add a pelvic lymphadenectomy in stages IA2-IB1,and additional adjuvant treatment is recommended once lymph node metastasis is confirmed. The Clinical guidelines of the therapy for high-risk EC is bilateral adnexectomy and radical hysterectomy.Endometrial cancer surgical treatment still remains controversial, particularly when the disease is in its early stages. According to the study, individuals with early-stage endometrial cancer may not receive any therapeutic benefit from a full lymphadenectomy.
However, comprehensive lymphadenectomy has many serious complications including lower extremity lymphedema, pelvic lymphocele, significant bleeding, nerve damage, and postoperative ileus etc. Comprehensive lymphadenectomy may compromise specific healthy lymph nodes' barrier and immunological functions, even to the extent that raising the chance of undetected cancer foci distant metastasizing. Inflammation, tumor size, malignant emboli, compression, physician detection approach, and patient history of neoadjuvant chemotherapy all impact the detection rate and Sensitivity of SLN.
The SLN mapping must have a small proportion of false-negative findings to be considered credible. To put it another way, a pathologically negative SLN must accurately reflect a pathologically negative condition of the ipsilateral pelvis. However, several prospective investigations show that the techniques have weak Sensitivity and a low positive predictive value below a generally recognized criterion of 90%.In this case, a non-invasive strategy has been applied to evaluate the occurrence of lymph node metastases using several imaging modalities. Magnetic resonance imaging (MRI) is the imaging modality used in the initial work-up to study the primary tumor and pelvic lymph node involvement. The use of imaging technologies, such as CT, MRI, PET, and DWI, may enable the accurate detection of pelvic and para-aortic LN metastases in cervical cancer patients as medical science and technology advance. Based on assessments of node size and/or morphologic information, LN metastases have traditionally and widely been detected using MRI.
Aiming to detect early CC and EC patients with lymph node metastases, our study evaluated the Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the preoperative MRI and SLN mapping, alone or in combination, try to find a simpler and safer method for correct diagnosis of lymph node metastasis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLN/MRI | Other | Drug: ICG/ blue dye |
Who may qualify
- Ages
- 41 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histopathological diagnosis of cervical cancer or endometrial cancer
- complete case data
- preoperative MRI examinations completed
- initial treatment is surgical
- all surgeries are entirely staged.
Key exclusion criteria (4 listed)
- patients with suspected extrauterine involvement
- allergic to tracers
- previous history of surgery or radiotherapy to nodal areas
- contraindication for surgical treatment (due to age or comorbidities).
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 |
|---|---|---|
| ICG/ blue dyeThe SLN mapping procedure was performed as previously described by using IGC or blue dye. The injection technique of the tracers was the same for both cervical and endometrial cancer. The cervical injection was done by insulin syringe(one ml) inserting full needle length (1 cm) and complete injection at 3, 9 o'clock, or 2,4,8,10 o'clock. | Drug | SLN/MRI |
Primary outcome
Sensitivity of the preoperative MRI and SLN mapping, alone or in combination
Time frame: 7 days
Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The Sensitivity, of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
specificity of the preoperative MRI and SLN mapping, alone or in combination
Time frame: 7 days
Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The specificity, of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
positive predictive value (PPV) of the preoperative MRI and SLN mapping, alone or in combination
Time frame: 7 days
Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The PPV of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
negative predictive value (NPV) of the preoperative MRI and SLN mapping, alone or in combination
Time frame: 7 days
Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The NPV of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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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.
Yu Zhao, master study chair
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG/ blue dye in people with Sentinel Lymph Node Biopsy and MRI, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 5 inclusion and 4 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 12 Jul 2023. 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 China. 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?
Sensitivity of the preoperative MRI and SLN mapping, alone or in combination (time frame: 7 days). The study lists 4 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 12 Jul 2023.