TITANIUM

• Research type

  Research Study

• Full title

  GestaTIonal TrophoblAstic NeoplasIa Ultrasound assessMent: TITANIUM study

• IRAS ID

  324194

• Contact name

  Michael Seckl

• Contact email

  m.seckl@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  4 years, 11 months, 31 days

• Research summary

  Gestational trophoblastic disease (GTD) is a group of disorders, arising from abnormal trophoblastic tissue proliferation during or after any type of pregnancy. Currently, ultrasound evaluation has a triple role in gestational trophoblastic disorders: diagnostic, prognostic and follow up. There are only few data regarding the possibility to use Grey scale and Doppler ultrasound to assess longitudinally the response to chemotherapy in gestational trophoblastic neoplasia.

  Study participants will have a baseline ultrasound prior to starting chemotherapy to assess their GTD. Their baseline hCG and staging will also be recorded. Finally, their response to chemotherapy will be documented.

  The aims of the study are:
  1. To describe typical gray scale and color Doppler ultrasound features of Gestational Trophooblastic Neoplasia at the baseline US examination
  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
  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 modeling
  4. To investigate if machine learning (ML) algorithms (radiomics, deep neural networks (DNN), and other machine learning algorithms), applied on ultrasound images, can discriminate 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 patients.

• REC name

  Wales REC 4

• REC reference

  23/WA/0247

• Date of REC Opinion

  18 Oct 2023

• REC opinion

  Further Information Favourable Opinion