Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05942170 |
Other study ID # |
SAHoWMU-CR2023-07-101 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2017 |
Est. completion date |
January 12, 2024 |
Study information
Verified date |
February 2023 |
Source |
Second Affiliated Hospital of Wenzhou Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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.
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.