NCT03404076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

5.9 years

First QC Date

November 3, 2017

Last Update Submit

April 6, 2022

Conditions

Gastrointestinal Stromal Tumor (GIST)

Keywords

Gastrointestinal Stromal Tumor (GIST)Dual Energy CTTyrosine Kinase Inhibitor (TKI)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

GIST patients under TKI treatment

GIST patients under TKI treatment are subjected to Dual Energy CT

Diagnostic Test: Dual Energy CT

Interventions

Dual Energy CTDIAGNOSTIC_TEST

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

GIST patients under TKI treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

gastrointestinal stromal (GIST) patients under tyrosine kinase inhibitor (TKI) treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Center Mannheim

Mannheim, Germany

Location

Related Publications (7)

  • 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.

    PMID: 19620483BACKGROUND

  • 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.

    PMID: 21822784BACKGROUND

  • 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.

    PMID: 21934517BACKGROUND

  • 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.

    PMID: 20498609BACKGROUND

  • 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.

    PMID: 18677487BACKGROUND

  • 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.

    PMID: 18796658BACKGROUND

  • 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. doi: 10.1148/radiol.2331031535. Epub 2004 Aug 10.

    PMID: 15304661BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Peter Hohenberger, Prof., MD

    Clinical for Surgery, Section SCOTCH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

November 3, 2017

First Posted

January 19, 2018

Study Start

December 1, 2014

Primary Completion

October 31, 2020

Study Completion

December 1, 2020

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)