Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01276483
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
Mona-Elisabeth Revheim, Oslo University Hospital

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.

Condition or disease
Soft Tissue Neoplasms Gastrointestinal Tract

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI
Study Start Date : February 2011
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 21, 2017

Primary Outcome Measures :
  1. Radiologic-pathologic correlation [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
GIST patients suitable for medical treatment with targeted therapies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01276483

Oslo University Hosptal
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mona-Elisabeth Revheim, Nuclear Medicine Phycisian, Oslo University Hospital Identifier: NCT01276483     History of Changes
Other Study ID Numbers: REK-2010/2089
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by Mona-Elisabeth Revheim, Oslo University Hospital:
Response Monitoring
Functional Magnetic Imaging
Positron Emission Tomography
Computer Tomography

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Soft Tissue Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site