MeningiomaDOTATATE-RTNCT06937268
DOTATATE PET for Meningioma Radiation Planning
A study testing DOTATATE-PET scan in people with Meningioma, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
68Ga-DOTATATE-based radionuclides are a novel modality in the diagnosis and treatment of central nervous system meningioma. DOTATATE is a ligand for the SSTR (somatostatin receptor), which is expressed in meningioma but not in normal brain or bone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- DOTATATE-PET scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Able and willing to comply with the study procedures
- Intact meningioma requiring definitive radiation
- Post-operative meningioma requiring adjuvant radiation
- No prior radiation therapy or medical therapy directed at the tumour
Who cannot join
- Breastfeeding or pregnancy
- Claustrophobia or inability to lie still in a supine position
- Unwillingness or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
Sandy Chang, sandy.chang@bccancer.bc.ca
Justin Oh, BA, MD, FRCPC
About this study
Official title: Exploratory Analysis of DOTATATE PET for Meningioma Radiation Planning
68Ga-DOTATATE-based radionuclides are a novel modality in the diagnosis and treatment of central nervous system meningioma. DOTATATE is a ligand for the SSTR (somatostatin receptor), which is expressed in meningioma but not in normal brain or bone. It is also more effective than MRI in delineating tumor, which is the current imaging standard for assessing meningioma. For radiation planning, it can help to reduce the risk of geometrical miss, identify area that require dose-escalation, and reduce dose to normal tissue. The purpose of the study is to compare the radiation therapy (RT) contouring and planning for meningioma with and without the use of 68Ga-DOTATATE-PET
- Conditions
- Meningioma
- Being tested
- DOTATATE-PET scan
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOTATATE-PET scanDiagnostic test
DOTATATE tracer PET scan for meningioma
| Study group | Role | What they receive |
|---|---|---|
| DOTATATE-PET scan | Experimental | Not described Receives: Diagnostic Test: DOTATATE-PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target radiation volume
The volume of gross total volume (GTV), clinical target volume (CTV), planned target volume (PTV) contours, and volume of dose exposure to normal brain tissue using standard imaging and DOTATE-PET scan
Measured: 2 years
Secondary outcomes (7)
Local control
Measured: 2 years
Progression-free survival
Measured: 2 years
Perceived usefulness by radiation oncologist
Measured: 2 years
Adverse event
Measured: 2 years
Rate of DOTATATE-scan completion
Measured: 2 years
Extent of post-operative disease volume compared to MRI
Measured: 2 years
Overall survival
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 posted22 Apr 2025
- Study startJun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937268
- Sponsor's protocol ID
- H22-03733
- Acronym
- DOTATATE-RT
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Analysis of DOTATATE PET for Meningioma Radiation Planning
- ClinicalTrials.gov ID
- NCT06937268
- Acronym / sponsor ID
- DOTATATE-RT / H22-03733
- Conditions
- Meningioma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- 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.
68Ga-DOTATATE-based radionuclides are a novel modality in the diagnosis and treatment of central nervous system meningioma. DOTATATE is a ligand for the SSTR (somatostatin receptor), which is expressed in meningioma but not in normal brain or bone. It is also more effective than MRI in delineating tumor, which is the current imaging standard for assessing meningioma. For radiation planning, it can help to reduce the risk of geometrical miss, identify area that require dose-escalation, and reduce dose to normal tissue. The purpose of the study is to compare the radiation therapy (RT) contouring and planning for meningioma with and without the use of 68Ga-DOTATATE-PET
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOTATATE-PET scan | Experimental | Diagnostic Test: DOTATATE-PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Able and willing to comply with the study procedures
- Intact meningioma requiring definitive radiation
- Post-operative meningioma requiring adjuvant radiation
- No prior radiation therapy or medical therapy directed at the tumour
Key exclusion criteria (3 listed)
- Breastfeeding or pregnancy
- Claustrophobia or inability to lie still in a supine position
- Unwillingness or inability to provide informed consent
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 |
|---|---|---|
| DOTATATE-PET scanDOTATATE tracer PET scan for meningioma | Diagnostic test | DOTATATE-PET scan |
Primary outcome
Target radiation volume
Time frame: 2 years
The volume of gross total volume (GTV), clinical target volume (CTV), planned target volume (PTV) contours, and volume of dose exposure to normal brain tissue using standard imaging and DOTATE-PET scan
7 secondary outcomes
Local control
Time frame: 2 years
Progression-free survival
Time frame: 2 years
Perceived usefulness by radiation oncologist
Time frame: 2 years
Adverse event
Time frame: 2 years
Rate of DOTATATE-scan completion
Time frame: 2 years
Extent of post-operative disease volume compared to MRI
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DOTATATE-PET scan in people with Meningioma, run by British Columbia Cancer Agency at 1 site in Canada.
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 5 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: opening soon, as of the sponsor's last update on 22 Apr 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandy Chang (6048776000, sandy.chang@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target radiation volume (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2025.