NCT01276483

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

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

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

6.3 years

First QC Date

January 12, 2011

Last Update Submit

June 21, 2017

Conditions

Keywords

GISTResponse MonitoringFunctional Magnetic ImagingPositron Emission TomographyComputer Tomography

Outcome Measures

Primary Outcomes (1)

  • Radiologic-pathologic correlation

    2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

GIST patients suitable for medical treatment with targeted therapies.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hosptal

Oslo, 0424, Norway

Location

Related Publications (1)

  • Revheim ME, Hole KH, Bruland OS, Reitan E, Bjerkehagen B, Julsrud L, Seierstad T. Multimodal functional imaging for early response assessment in GIST patients treated with imatinib. Acta Oncol. 2014 Jan;53(1):143-8. doi: 10.3109/0284186X.2013.798428. Epub 2013 May 28. No abstract available.

MeSH Terms

Conditions

Soft Tissue Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Mona-Elisabeth Revheim, MD

    Oslo University Hospital, Dept of Nuclear Medicine

    PRINCIPAL INVESTIGATOR
  • Therese Seierstad, PhD

    Oslo University Hospital, Institute for Cancer Research

    STUDY CHAIR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nuclear Medicine Phycisian

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2017

Study Completion

June 21, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Locations