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Radiopharmaceutical

Radio-guided Surgery for Meningioma

Phase 4
Recruiting
Led By Jana Ivanidze, MD/PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of meningioma based on pathology reports from prior resection with radiographic findings of suspected recurrent or residual tumor necessitating repeat surgery
High suspicion of meningioma necessitating surgical resection based on conventional MRI criteria
Must not have
Patients with prior history of cranial radiation therapy
Patients undergoing endoscopic endonasal resection, eyebrow incision surgery, or any surgical procedure in which the neoprobe cannot be employed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to test if it is possible to use a gamma probe device to find tumors during surgery after injecting a specific substance called [CU64]DOTATATE.

Who is the study for?
This trial is for individuals with meningioma, a type of brain tumor. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have no conditions that could interfere with the study.
What is being tested?
The trial is testing if injecting [Cu64]DOTATATE, which helps highlight tumors, can be used during surgery to better detect meningioma using a special device called a gamma probe.
What are the potential side effects?
Potential side effects are not detailed in the information provided. However, similar procedures may include risks from radiation exposure and reactions to the tracer substance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a meningioma diagnosis and need another surgery for a suspected return or leftover tumor.
Select...
I am likely to have a brain tumor that needs surgery, as seen on an MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had radiation therapy to my brain before.
Select...
I am having surgery that doesn't allow for a special probe to be used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
1st Post-operative [Cu64]DOTATATE PET SUV
2nd Post-operative [Cu64]DOTATATE PET SUV
GTR vs STR Assessment
+6 more
Secondary study objectives
ER/PR expression
Ki67 Proliferation Index
SSTR2 expression
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with MRI findings compatible with meningioma who have an indication for surgeryExperimental Treatment2 Interventions
A diagnostic intervention in which patients will undergo intraoperative meningioma tracing using \[Cu64\]DOTATATE.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,087 Previous Clinical Trials
1,148,727 Total Patients Enrolled
2 Trials studying Meningioma
206 Patients Enrolled for Meningioma
Curium US LLCIndustry Sponsor
5 Previous Clinical Trials
1,026 Total Patients Enrolled
Jana Ivanidze, MD/PhDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
20 Total Patients Enrolled
~7 spots leftby Jan 2025
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