DOTATATE PET for Meningioma Radiation Planning (DOTATATE-RT)

April 15, 2025 updated by: British Columbia Cancer Agency

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DOTATATE-PET scan
Diagnostic test: DOTATATE-PET scan
DOTATATE tracer PET scan for meningioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years
Progression-free survival
Time Frame: 2 years
2 years
Adverse event
Time Frame: 2 years
2 years
Local control
Time Frame: 2 years
2 years
Perceived usefulness by radiation oncologist
Time Frame: 2 years
2 years
Rate of DOTATATE-scan completion
Time Frame: 2 years
2 years
Extent of post-operative disease volume compared to MRI
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H22-03733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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