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Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01276483
First Posted: January 13, 2011
Last Update Posted: June 22, 2017
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.
Information provided by (Responsible Party):
Mona-Elisabeth Revheim, Oslo University Hospital
  Purpose
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
Soft Tissue Neoplasms Gastrointestinal Tract

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI

Resource links provided by NLM:


Further study details as provided by Mona-Elisabeth Revheim, Oslo University Hospital:

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

Enrollment: 40
Study Start Date: February 2011
Study Completion Date: June 21, 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
  Eligibility

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.
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01276483


Locations
Norway
Oslo University Hosptal
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mona-Elisabeth Revheim, Nuclear Medicine Phycisian, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01276483     History of Changes
Other Study ID Numbers: REK-2010/2089
First Submitted: January 12, 2011
First Posted: January 13, 2011
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by Mona-Elisabeth Revheim, Oslo University Hospital:
GIST
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
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site