GISTm3: Unifying Advanced Treatment With Advanced Imaging

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT03404076
Collaborator
Institute of Clinical Radiology and Nuclear Medicine Mannheim (Other), Siemens Healthcare Diagnostics Inc (Industry), Novartis Pharmaceuticals (Industry)
93
1
72
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Dual Energy CT

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.

Study Design

Study Type:
Observational
Actual Enrollment :
93 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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.
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
GIST patients under TKI treatment

GIST patients under TKI treatment are subjected to Dual Energy CT

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

Outcome Measures

Primary Outcome Measures

  1. Progression free survival after a three year follow-up [3 years follow up]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Center Mannheim Mannheim Germany

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Peter Hohenberger, Prof., MD, Clinical for Surgery, Section SCOTCH

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peter Hohenberger, Prof. Dr. med., Heidelberg University
ClinicalTrials.gov Identifier:
NCT03404076
Other Study ID Numbers:
  • GIST m3
First Posted:
Jan 19, 2018
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peter Hohenberger, Prof. Dr. med., Heidelberg University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022