Ultrasound assessment of gestational trophoblastic neoplasia

Gestional Trophoblastic Neoplasia Ultrasound Assessment: Titanium Study

This study is trying to see how ultrasound can help doctors understand gestational trophoblastic neoplasia better and predict how well low-risk patients will respond to treatment.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Rome)
• Trial ID: NCT06284980 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize the ultrasound features of gestational trophoblastic neoplasia (GTN) and assess differences between low-risk and high-risk patients. It will identify ultrasound predictors of resistance to first-line chemotherapy in low-risk GTN patients and explore the use of machine learning algorithms to improve prediction accuracy. The study will also monitor changes in ultrasound characteristics during and after treatment. By analyzing these factors, the research seeks to enhance the management of GTN.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with gestational trophoblastic neoplasia after any pregnancy event.

Not a fit: Patients without a confirmed diagnosis of gestational trophoblastic neoplasia or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with gestational trophoblastic neoplasia.

How similar studies have performed: While there have been studies on ultrasound features in GTN, the integration of machine learning for predicting chemoresistance is a novel approach.

Eligibility criteria

Inclusion Criteria:

* Patients with a diagnosis of Gestational Trophoblastic Neoplasia (GTN), after any kind of pregnancy:

  1. Histological diagnosis of Placental Site Trophoblastic Tumor or Epithelioid Trophoblastic Tumor
  2. International Federation of Gynecology and Obstetrics (FIGO) 2002 criteria for the diagnosis of Gestational Trophoblastic Neoplasia I. Histological evidence of invasive mole or choriocarcinoma II. Rising hCG after evacuation of hydatidiform mole, i.e. two consecutive rises in hCG of 10% or greater over at least 2 weeks (at least 10% between day 1 and 7 and then again at least 10% between day 7 and 14) III. Plateau of hCG after evacuation of hydatidiform mole, i.e. four or more equivalent values of hCG over at least 3 weeks (days 1, 7, 14 and 21) IV. The hCG level remains elevated for 6 months or more after evacuation even if decreasing
  3. Charing Cross Hospital (UK) additional criteria for the diagnosis of Gestational Trophoblastic

     Neoplasia:

     I. Heavy vaginal bleeding or evidence of gastrointestinal or intraperitoneal hemorrhage in patients with histological diagnosis of GTD II. Serum hCG concentration of 20 000 IU/L or more 4 weeks or more after evacuation of a mole, because of the risk of uterine perforation III. Evidence of metastases in brain, liver, or gastrointestinal tract, or radiological opacities larger than 2 cm on chest radiograph in patients with GTD.

     Referral Centers for Gestational Trophoblastic Disease with at least 5 cases of GTN per year, that routinely use ultrasound in clinical evaluation, could participate in the study adhering to the:
* BASIC PROTOCOL if they are able to guarantee only the baseline ultrasound evaluation at the diagnosis but NOT the follow-up ultrasound scans during and after chemotherapy
* FULL PROTOCOL if they are able to guarantee both the baseline and all the follow-up ultrasound examination according to the complete protocol schedule.

Exclusion Criteria:

* EXCLUSION CRITERIA

  1. Previous or ongoing chemotherapy for GTN that started \>7 days earlier
  2. Denial of informed consent.

Where this trial is running

Rome

• Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: Floriana Mascilini — Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
• Study coordinator: Antonia Carla Testa

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 Algorithms, and Other Machine Learning Algorithms; Gestational Trophoblastic Neoplasia; Ultrasound; Gestational