Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

This study is currently recruiting participants.

Verified October 2012 by Oslo University Hospital

Sponsor:

Information provided by (Responsible Party):

Mona-Elisabeth Revheim, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01276483

First received: January 12, 2011

Last updated: October 12, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2011

Last Updated Date

October 12, 2012

Start Date ^ICMJE

February 2011

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01276483 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

Official Title ^ICMJE

Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI

Brief Summary

The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI and CT separately and combined for the evaluation of treatment response and progression-free survival in patients with GIST.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

GIST patients suitable for medical treatment with targeted therapies.

Condition ^ICMJE

Soft Tissue Neoplasms
Gastrointestinal Tract

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Metastatic GIST patients suitable for TKI treatment
GIST patients pursuing preoperative neoadjuvant TKI treatment

Exclusion Criteria:

Patients with contraindications to MRI and/or TKI treatment. For patients with renal failure, CT without intravenous contrast will be performed according to clinical practice.
Patients who do not sign the consent paper for any reason or do not accept the study premises or patients who wish to withdraw for any reason during the study

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Mona-Elisabeth Revheim, MD	+4723070840	mona.elisabeth.revheim@ous-hf.no
Contact: Therese Seierstad, PhD	+4722781237	therese@radium.uio.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01276483

Other Study ID Numbers ^ICMJE

REK-2010/2089

Has Data Monitoring Committee

Responsible Party

Mona-Elisabeth Revheim, Oslo University Hospital

Study Sponsor ^ICMJE

Oslo University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Mona-Elisabeth Revheim, MD	Oslo University Hospital, Dept of Nuclear Medicine
Study Chair:	Therese Seierstad, PhD	Oslo University Hospital, Institute for Cancer Research
Principal Investigator:	Øyvind S Bruland, Prof., MD	Oslo University Hospital, Dept of Oncology, The Norwegian Radium Hospital
Principal Investigator:	Knut Håkon Hole, MD	Oslo University Hospital, Department of Diagnostic Radiology
Principal Investigator:	Lars Julsrud, MD	Oslo University Hospital, Department of Diagnostic Radiology

Information Provided By

Oslo University Hospital

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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