Unifying Advanced Treatment With Advanced Imaging

Gastrointestinal Stromal Tumor (GIST) Clinical Trial

— GISTm3  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404076
• Other study ID #: GIST m3
• Status: Completed
• Start date: December 1, 2014
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 1, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor (GIST)
• Gastrointestinal Stromal Tumors

Intervention

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

Locations

Country	Name	City	State
Germany	University Center Mannheim	Mannheim

Sponsors (4)

Lead Sponsor	Collaborator
Heidelberg University	Institute of Clinical Radiology and Nuclear Medicine Mannheim, Novartis Pharmaceuticals, Siemens Healthcare Diagnostics Inc

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Apfaltrer P, Meyer M, Meier C, Henzler T, Barraza JM Jr, Dinter DJ, Hohenberger P, Schoepf UJ, Schoenberg SO, Fink C. Contrast-enhanced dual-energy CT of gastrointestinal stromal tumors: is iodine-related attenuation a potential indicator of tumor response? Invest Radiol. 2012 Jan;47(1):65-70. doi: 10.1097/RLI.0b013e31823003d2. — View Citation

Chae EJ, Song JW, Seo JB, Krauss B, Jang YM, Song KS. Clinical utility of dual-energy CT in the evaluation of solitary pulmonary nodules: initial experience. Radiology. 2008 Nov;249(2):671-81. doi: 10.1148/radiol.2492071956. Epub 2008 Sep 16. — View Citation

Graser A, Becker CR, Staehler M, Clevert DA, Macari M, Arndt N, Nikolaou K, Sommer W, Stief C, Reiser MF, Johnson TR. Single-phase dual-energy CT allows for characterization of renal masses as benign or malignant. Invest Radiol. 2010 Jul;45(7):399-405. doi: 10.1097/RLI.0b013e3181e33189. — View Citation

Graser A, Johnson TR, Chandarana H, Macari M. Dual energy CT: preliminary observations and potential clinical applications in the abdomen. Eur Radiol. 2009 Jan;19(1):13-23. doi: 10.1007/s00330-008-1122-7. Epub 2008 Aug 2. Review. — View Citation

Le Cesne A, Van Glabbeke M, Verweij J, Casali PG, Findlay M, Reichardt P, Issels R, Judson I, Schoffski P, Leyvraz S, Bui B, Hogendoorn PC, Sciot R, Blay JY. Absence of progression as assessed by response evaluation criteria in solid tumors predicts survival in advanced GI stromal tumors treated with imatinib mesylate: the intergroup EORTC-ISG-AGITG phase III trial. J Clin Oncol. 2009 Aug 20;27(24):3969-74. doi: 10.1200/JCO.2008.21.3330. Epub 2009 Jul 20. — View Citation

Schmid-Bindert G, Henzler T, Chu TQ, Meyer M, Nance JW Jr, Schoepf UJ, Dinter DJ, Apfaltrer P, Krissak R, Manegold C, Schoenberg SO, Fink C. Functional imaging of lung cancer using dual energy CT: how does iodine related attenuation correlate with standardized uptake value of 18FDG-PET-CT? Eur Radiol. 2012 Jan;22(1):93-103. doi: 10.1007/s00330-011-2230-3. Epub 2011 Aug 7. — View Citation

Yi CA, Lee KS, Kim EA, Han J, Kim H, Kwon OJ, Jeong YJ, Kim S. Solitary pulmonary nodules: dynamic enhanced multi-detector row CT study and comparison with vascular endothelial growth factor and microvessel density. Radiology. 2004 Oct;233(1):191-9. Epub 2004 Aug 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival after a three year follow-up	To visualize and to evaluate therapy response or stable disease of GIST patients undergoing TKI treatment by Dual Energy CT	3 years follow up