The Combination of Preoperative MRI and SLN in the Surgical Management of CC and EC

NCT05942170 | Unknown

• 1 other identifier: SAHoWMU-CR2023-07-101
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sentinel Lymph Node Biopsy; MRI

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  7 days

Study Arms (1)

SLN/MRI

OTHER

Drug: ICG/ blue dye

Interventions

ICG/ blue dye DRUG

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.

SLN/MRI

Eligibility Criteria

• Age: 41 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histopathological diagnosis of cervical cancer or endometrial cancer
• complete case data
• preoperative MRI examinations completed
• initial treatment is surgical
• all surgeries are entirely staged.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

Wenzhou, Zhejiang, 325000, China

Location

Study Officials

• Yu Zhao, master

  The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: July 12, 2023
• Study Start: February 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: January 12, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-02

Locations

CN (1)