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Unifying Advanced Treatment With Advanced Imaging

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03404076
Acronym
GISTm3
Enrollment
93
Registered
2018-01-19
Start date
2014-12-01
Completion date
2020-12-01
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumor (GIST)

Keywords

Gastrointestinal Stromal Tumor (GIST), Dual Energy CT, Tyrosine Kinase Inhibitor (TKI)

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTDual Energy CT

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

Sponsors

Institute of Clinical Radiology and Nuclear Medicine Mannheim
CollaboratorUNKNOWN
Siemens Healthcare Diagnostics Inc
CollaboratorINDUSTRY
Novartis Pharmaceuticals
CollaboratorINDUSTRY
Heidelberg University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression free survival after a three year follow-up3 years follow upTo visualize and to evaluate therapy response or stable disease of GIST patients undergoing TKI treatment by Dual Energy CT

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026