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Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study

NCT06284980 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-02-29

No results posted yet for this study

Summary

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.

Conditions

  • Describe Typical Gray Scale/Color Doppler Ultrasound Features of Gestational Trophoblastic Neoplasia at the US Examination
  • To Assess if There Are Differences at the Baseline US Scan Between Low-risk and High-risk Patients
  • To Identify Ultrasound Predictors of Resistance to First-line Single Drug Chemotherapy in Low-risk GTN Patients
  • To Investigate if Machine Learning (ML) Algorithms (Radiomics, Deep Neural Networks (DNN), and Other Machine Learning Algorithms

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Floriana Mascilini · Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2024-12-30
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284980 on ClinicalTrials.gov