NCT06937268

Brief 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. 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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress38%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

April 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

April 15, 2025

Last Update Submit

April 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (7)

  • Local control

    2 years

  • Progression-free survival

    2 years

  • Perceived usefulness by radiation oncologist

    2 years

  • Adverse event

    2 years

  • Rate of DOTATATE-scan completion

    2 years

  • +2 more secondary outcomes

Study Arms (1)

DOTATATE-PET scan

EXPERIMENTAL
Diagnostic Test: DOTATATE-PET scan

Interventions

DOTATATE-PET scanDIAGNOSTIC_TEST

DOTATATE tracer PET scan for meningioma

DOTATATE-PET scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Breastfeeding or pregnancy
  • Claustrophobia or inability to lie still in a supine position
  • Unwillingness or inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 22, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations