Skip to main content
OpenTrials
Completed

NCT Number: NCT03404076

Unifying Advanced Treatment With Advanced Imaging

The study investigates response assessment of gastrointestinal stromal tumors using Dual Energy CT (DECT) in patients undergoing targeted therapy with a TKI Inhibitor.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Patients treated with targeted therapies by tyrosine kinase inhibition (TKI) almost always show different response patterns than tumors treated with cytotoxic chemotherapy. Tumor manifestations treated with targeted therapies often show only minor measurable changes in tumor size despite inhibition of tumor proliferation. Decrease in tumor size fulfilling the criteria of a partial remission according to RECIST may occur at a delayed stage of treatment after several months (PMID 19620483). Sometimes, even an initial increase of maximum tumor diameters may be observed although those patients are treatment responders with respect to 'hard' study endpoints like overall survival or progression free survival. As a result, patients often are misclassified too early as non-responders. As a consequence, successful treatment is not recognized or decisions towards a less effective second-line therapy are made.

Dual Energy CT (DECT) is a new and robust CT method that allows to exactly quantify the intra-tumoral amount of intravenously injected iodinated contrast material PMID 21822784). Thus, the technique can be considered as a simple and reliable surrogate of tumor Perfusion (PMID 21822784, 21934517, 20498609, 18677487). Initial studies have demonstrated a high accuracy of DECT in the differentiation of benign and malignant tumors in the kidney or lung (PMID 20498609, 18677487, 18796658). Furthermore, it has been demonstrated that the amount of iodine in lung tumors correlates with tumor glucose metabolism (PMID 21822784). These findings confirm the results of previous studies that have demonstrated the relationship between tumor perfusion, tumor microvessel density and glucose metabolism (PMID 15304661).

The hypothesis of the study is that DECT is the more accurate diagnostic tool to evaluate immediate therapeutic response in patients with GIST undergoing TKI inhibitor therapy (in most cases Glivec ®) than evaluating by RECIST, World Health Organization (WHO) and Choi criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • General inclusion criteria for TKI treatment according to general medical standard procedures

Exclusion criteria

  • General inclusion criteria for TKI treatment according to general medical standard procedures

Treatment and study plan

Dual Energy CT

Diagnostic Test

Dual Energy CT is performed for diagnostic evaluation in gastrointestinal stromal tumor (GIST) patients undergoing tyrosine kinase inhibitor (TKI) treatment

Primary outcomes

  1. Progression free survival after a three year follow-up

    Time frame: 3 years follow up

    To visualize and to evaluate therapy response or stable disease of GIST patients undergoing TKI treatment by Dual Energy CT

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • Institute of Clinical Radiology and Nuclear Medicine Mannheim
  • Novartis Pharmaceuticals
  • Siemens Healthcare Diagnostics Inc

Registry information

Official study title

Optimized Response Assessment of Gastrointestinal Stromal Tumors Using Dual-Energy CT: Prospective Multicenter-Multinational Trial in Patients Undergoing Targeted Therapy With a TKI Inhibitor.

Acronym: GISTm3

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jan 19, 2018
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.