Gastrointestinal Stromal Tumor (GIST)GISTm3NCT03404076
Unifying Advanced Treatment With Advanced Imaging
An observational study of Gastrointestinal Stromal Tumor (GIST), run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor (GIST)
- What is being tested?
- Dual Energy CT
- How many people
- 93 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2014to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: gastrointestinal stromal (GIST) patients under tyrosine kinase inhibitor (TKI) treatment
Who may be able to join
- General inclusion criteria for TKI treatment according to general medical standard procedures
Who cannot join
- General inclusion criteria for TKI treatment according to general medical standard procedures
Trial locations and contacts
1 site in 1 country.
About this study
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.
The study investigates response assessment of gastrointestinal stromal tumors using Dual Energy CT (DECT) in patients undergoing targeted therapy with a TKI Inhibitor.
Read the 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.
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Being tested
- Dual Energy CT
- Keywords
- Gastrointestinal Stromal Tumor (GIST), Dual Energy CT, Tyrosine Kinase Inhibitor (TKI)
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Energy CTDiagnostic test
Dual Energy CT is performed for diagnostic evaluation in gastrointestinal stromal tumor (GIST) patients undergoing tyrosine kinase inhibitor (TKI) treatment
| Study group | Role | What they receive |
|---|---|---|
| GIST patients under TKI treatment | GIST patients under TKI treatment are subjected to Dual Energy CT Receives: Diagnostic Test: Dual Energy CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Dec 2014
- Primary completion31 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal Tumor (GIST)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Clinical Radiology and Nuclear Medicine Mannheim, Siemens Healthcare Diagnostics Inc, Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Peter Hohenberger, Heidelberg University
- Investigators
- Peter Hohenberger, Prof., MD, Principal investigator, Clinical for Surgery, Section SCOTCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404076
- Sponsor's protocol ID
- GIST m3
- Acronym
- GISTm3
- Status last verified
- Apr 2022
- First submitted
- 3 Nov 2017
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19620483Schmid-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.
PubMed 21822784Apfaltrer 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.
PubMed 21934517Graser 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.
PubMed 20498609Graser 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.
PubMed 18677487Chae 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.
PubMed 18796658Yi 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.
PubMed 15304661Meyer M, Ota H, Messiou C, Benson C, Henzler T, Mattonen SA, Marin D, Bartsch A, Schoenberg SO, Riedel RF, Hohenberger P. Prospective evaluation of quantitative response parameter in patients with Gastrointestinal Stroma Tumor undergoing tyrosine kinase inhibitor therapy-Impact on clinical outcome. Int J Cancer. 2024 Dec 1;155(11):2047-2057. doi: 10.1002/ijc.35094. Epub 2024 Jul 18.
PubMed 39023303
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03404076
- Acronym / sponsor ID
- GISTm3 / GIST m3
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Keywords
- Gastrointestinal Stromal Tumor (GIST), Dual Energy CT, Tyrosine Kinase Inhibitor (TKI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Institute of Clinical Radiology and Nuclear Medicine Mannheim, Siemens Healthcare Diagnostics Inc, Novartis Pharmaceuticals
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GIST patients under TKI treatment | – | Diagnostic Test: Dual Energy CTGIST patients under TKI treatment are subjected to Dual Energy CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gastrointestinal stromal (GIST) patients under tyrosine kinase inhibitor (TKI) treatment
Key inclusion criteria (1 listed)
- General inclusion criteria for TKI treatment according to general medical standard procedures
Key exclusion criteria (1 listed)
- General inclusion criteria for TKI treatment according to general medical standard procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Energy CTDual Energy CT is performed for diagnostic evaluation in gastrointestinal stromal tumor (GIST) patients undergoing tyrosine kinase inhibitor (TKI) treatment | Diagnostic test | GIST patients under TKI treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 19620483Le 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.
- Background: PubMed 21822784Schmid-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.
- Background: PubMed 21934517Apfaltrer 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.
- Background: PubMed 20498609Graser 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.
- Background: PubMed 18677487Graser 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.
- Background: PubMed 18796658Chae 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.
- Background: PubMed 15304661Yi 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.
- Derived from this study: PubMed 39023303Meyer M, Ota H, Messiou C, Benson C, Henzler T, Mattonen SA, Marin D, Bartsch A, Schoenberg SO, Riedel RF, Hohenberger P. Prospective evaluation of quantitative response parameter in patients with Gastrointestinal Stroma Tumor undergoing tyrosine kinase inhibitor therapy-Impact on clinical outcome. Int J Cancer. 2024 Dec 1;155(11):2047-2057. doi: 10.1002/ijc.35094. Epub 2024 Jul 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Hohenberger, Prof., MD principal investigator
Clinical for Surgery, Section SCOTCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumor (GIST), run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival after a three year follow-up (time frame: 3 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03404076, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.