GliomaPhase 2/3DOTAGLINCT01460706
Imaging Malignant Glioma With 68Ga-DOTATOC PET/CT
A Phase 2/3 study testing [68Ga]DOTATOC in people with Glioma, run by Turku University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma
- What is being tested?
- [68Ga]DOTATOC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2011to Dec 2013
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 70 years old
- Language spoken: Finnish or Swedish
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Supratentorial malignant glioma based on MRI imaging
- Supratentorial recurrent glioma based on MRI and/or [11C]methionine PET imaging
- Patients must be able to understand the meaning of the study and sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff
Who cannot join
- Any medical or psychiatric condition that compromises the subject´s ability to participate in the study
- Any other significant disease including liver or renal disease
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC
The purpose of this study is to characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.
- Conditions
- Glioma
- Being tested
- [68Ga]DOTATOC
- Keywords
- Glioma, 68Ga-DOTATOC, PET/CT, Somatostatin receptor
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]DOTATOCDrug
120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTATOC | Experimental | Not described Receives: Drug: [68Ga]DOTATOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant glioma uptake of 68Ga-DOTATOC
PET/CT imaging of the brain starts immediately after the intravenous bolus injection of 68Ga-DOTATOC. Dynamic PET/CT imaging is done over 60-min. A late 90-min scan will be obtained for selected patients. PET studies are analyzed by determining the Standardized Uptake Values (SUV) of the tumor using regions of interest (ROI) drawn both manually and automatically on the tumor.
Measured: within 90 minutes post-injection
Secondary outcomes (1)
Immunohistochemical SST2 receptor status of the tumor specimen
Measured: After glioma surgery within 4 weeks of PET/CT imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionDec 2013
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 GliomaStudies of the same condition, open and under way.
- More trials run by Turku 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heikki Minn, Turku University Hospital
- Investigators
- Heikki RI Minn, M.D., Ph.D., Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460706
- Sponsor's protocol ID
- 77/180/2010
- Acronym
- DOTAGLI
- Status last verified
- Dec 2013
- First submitted
- 25 Oct 2011
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kiviniemi A, Gardberg M, Frantzen J, Pesola M, Vuorinen V, Parkkola R, Tolvanen T, Suilamo S, Johansson J, Luoto P, Kemppainen J, Roivainen A, Minn H. Somatostatin receptor subtype 2 in high-grade gliomas: PET/CT with (68)Ga-DOTA-peptides, correlation to prognostic markers, and implications for targeted radiotherapy. EJNMMI Res. 2015 Apr 22;5:25. doi: 10.1186/s13550-015-0106-2. eCollection 2015.
PubMed 25977882
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT Imaging of Malignant Glioma With Somatostatin Analog 68Ga-DOTATOC
- ClinicalTrials.gov ID
- NCT01460706
- Acronym / sponsor ID
- DOTAGLI / 77/180/2010
- Conditions
- Glioma
- Keywords
- Glioma, 68Ga-DOTATOC, PET/CT, Somatostatin receptor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Oct 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 characterize tumour uptake of somatostatin analog 68Ga-DOTATOC in patients with either primary or recurrent malignant glioma. The investigators hypothesis is that some primary and recurrent malignant gliomas overexpress SST2 receptor which can be imaged with 68Ga-DOTATOC PET/CT. The investigators also hypothesize that tumor uptake of 68Ga-DOTATOC correlates with immunohistochemically determined SST2 receptor status of the tumor specimen.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTATOC | Experimental | Drug: [68Ga]DOTATOC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 to 70 years old
- Language spoken: Finnish or Swedish
- Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- Supratentorial malignant glioma based on MRI imaging
- Supratentorial recurrent glioma based on MRI and/or [11C]methionine PET imaging
Key exclusion criteria (3 listed)
- Any medical or psychiatric condition that compromises the subject´s ability to participate in the study
- Any other significant disease including liver or renal disease
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]DOTATOC120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery. | Drug | 68Ga-DOTATOC |
Primary outcome
Malignant glioma uptake of 68Ga-DOTATOC
Time frame: within 90 minutes post-injection
PET/CT imaging of the brain starts immediately after the intravenous bolus injection of 68Ga-DOTATOC. Dynamic PET/CT imaging is done over 60-min. A late 90-min scan will be obtained for selected patients. PET studies are analyzed by determining the Standardized Uptake Values (SUV) of the tumor using regions of interest (ROI) drawn both manually and automatically on the tumor.
1 secondary outcome
Immunohistochemical SST2 receptor status of the tumor specimen
Time frame: After glioma surgery within 4 weeks of PET/CT imaging
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 12 Dec 2013.
- Derived from this study: PubMed 25977882Kiviniemi A, Gardberg M, Frantzen J, Pesola M, Vuorinen V, Parkkola R, Tolvanen T, Suilamo S, Johansson J, Luoto P, Kemppainen J, Roivainen A, Minn H. Somatostatin receptor subtype 2 in high-grade gliomas: PET/CT with (68)Ga-DOTA-peptides, correlation to prognostic markers, and implications for targeted radiotherapy. EJNMMI Res. 2015 Apr 22;5:25. doi: 10.1186/s13550-015-0106-2. eCollection 2015.
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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.
Heikki RI Minn, M.D., Ph.D. principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing [68Ga]DOTATOC in people with Glioma, run by Turku University Hospital at 1 site in Finland.
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 6 inclusion and 3 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 12 Dec 2013. 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 Finland. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Malignant glioma uptake of 68Ga-DOTATOC (time frame: within 90 minutes post-injection). 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 NCT01460706, 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 12 Dec 2013.