Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination Clinical Trial
Official title:
Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study
Gestational trophoblast diseases are characterized by abnormal proliferation of trophoblastic tissue, which can occur consequent to any pregnancy event. Pre-malignant forms (partial hydatiform mola and complete mola) and malignant forms are distinguished, the latter also known as gestational trophoblast neoplasms (invasive hydatiform mola, choriocarcinoma, placental site trophoblastic tumor, and epithelioid trophoblastic tumor). These are neoplasms associated with good prognosis, amenable to conservative treatment and highly sensitive to chemotherapy. The identification of ultrasonographic and echofluximetric features typical of malignant forms as well as the identification of ultrasonographic parameters predictive of chemoresistance to single-drug treatments could help improve their management.
Primary aim 1. To describe typical gray scale and color Doppler ultrasound features of Gestational Troph-oblastic Neoplasia at the baseline US examination; the results will be presented as in Table 4 2. To assess if there are differences at the baseline US scan between low-risk and high-risk patients and, in the low-risk group, between responders and non-responders to the single drug therapy; the results will be presented as in Table 5 3. To identify ultrasound predictors of resistance to first-line single drug chemotherapy in low-risk GTN patients; statistical analysis will be performed using logistic regression mod-eling 4. To investigate if machine learning (ML) algorithms (radiomics, deep neural networks (DNN), and other machine learning algorithms), applied on ultrasound images, can dis-criminate between low-risk patients that will or will not develop chemoresistance to single-drug therapy.To investigate if ML algorithms, combined with the conventional risk-score improve prediction of resistance to first-line single drug chemotherapy in low risk GTN pa-tients. Secondary aims: I. To describe any longitudinal changes in ultrasound characteristics of Gestational Tropho-blastic Neoplasia during treatment. I. To describe any longitudinal changes in ultrasound characteristics of Gestational Tropho-blastic Neoplasia after stopping treatment, when the uterine lesion is still visible despite the normalization of hCG. ;