Soft Tissue NeoplasmsNCT01276483
Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients
An observational study of Soft Tissue Neoplasms and Gastrointestinal Tract, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Neoplasms, Gastrointestinal Tract
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2011to 21 Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: GIST patients suitable for medical treatment with targeted therapies.
Who may be able to join
- Metastatic GIST patients suitable for TKI treatment
- GIST patients pursuing preoperative neoadjuvant TKI treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI
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.
- Conditions
- Soft Tissue Neoplasms, Gastrointestinal Tract
- Keywords
- GIST, Response Monitoring, Functional Magnetic Imaging, Positron Emission Tomography, Computer Tomography
- Medical subject headings
- Soft Tissue Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic-pathologic correlation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue NeoplasmsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona-Elisabeth Revheim, Oslo University Hospital
- Investigators
- Mona-Elisabeth Revheim, MD, Principal investigator, Oslo University Hospital, Dept of Nuclear MedicineTherese Seierstad, PhD, Study chair, Oslo University Hospital, Institute for Cancer ResearchØyvind S Bruland, Prof., MD, Principal investigator, Oslo University Hospital, Dept of Oncology, The Norwegian Radium HospitalKnut Håkon Hole, MD, Principal investigator, Oslo University Hospital, Department of Diagnostic RadiologyLars Julsrud, MD, Principal investigator, Oslo University Hospital, Department of Diagnostic Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276483
- Sponsor's protocol ID
- REK-2010/2089
- Status last verified
- Jun 2017
- First submitted
- 12 Jan 2011
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23710697
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI
- ClinicalTrials.gov ID
- NCT01276483
- Acronym / sponsor ID
- REK-2010/2089
- Conditions
- Soft Tissue Neoplasms, Gastrointestinal Tract
- Keywords
- GIST, Response Monitoring, Functional Magnetic Imaging, Positron Emission Tomography, Computer Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 13 Jan 2011 (estimated)
- 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- GIST patients suitable for medical treatment with targeted therapies.
Key inclusion criteria (2 listed)
- Metastatic GIST patients suitable for TKI treatment
- GIST patients pursuing preoperative neoadjuvant TKI treatment
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiologic-pathologic correlation
Time frame: 2 years
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 22 Jun 2017.
- Derived from this study: PubMed 23710697Revheim 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.
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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.
Mona-Elisabeth Revheim, MD principal investigator
Oslo University Hospital, Dept of Nuclear Medicine
Therese Seierstad, PhD study chair
Oslo University Hospital, Institute for Cancer Research
Øyvind S Bruland, Prof., MD principal investigator
Oslo University Hospital, Dept of Oncology, The Norwegian Radium Hospital
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 Soft Tissue Neoplasms and Gastrointestinal Tract, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 2 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 22 Jun 2017. 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 Norway. 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?
Radiologic-pathologic correlation (time frame: 2 years). 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 NCT01276483, which also lists 1 linked publication.
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 22 Jun 2017.