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Radiopharmaceutical

Patients with MRI findings compatible with meningioma who have an indication for surgery for Meningioma

Phase 4

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

1st Post-operative [Cu64]DOTATATE PET SUV

2nd Post-operative [Cu64]DOTATATE PET SUV

GTR vs STR Assessment

+6 more

Secondary outcome measures

ER/PR expression

Ki67 Proliferation Index

SSTR2 expression

+1 more

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,316,278 Total Patients Enrolled

2 Trials studying Meningioma

206 Patients Enrolled for Meningioma

Curium US LLCIndustry Sponsor

5 Previous Clinical Trials

991 Total Patients Enrolled

Jana Ivanidze, MD/PhDPrincipal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 45 eligible to participate in this clinical trial?

"To be considered for participation in this research study, candidates must fall within the age range of 18 to 99. Notably, there are separate clinical trials available for individuals under 18 and those over 65 years old - with a total of 8 studies catering to the former group and 47 to the latter."

Answered by AI

Are new participants currently being welcomed to enroll in this trial?

"As per clinicaltrials.gov, the current trial is not in active recruitment. It was initially listed on April 1st, 2024 and last revised on April 18th, 2024. Despite this trial being inactive regarding patient enrollment currently, there are over fifty other trials open for participant recruitment."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The main goal of this research is to assess the [Cu64]DOTATATE PET SUV within approximately at enrollment. Secondary aims include evaluating ER/PR expression, SSTR2 expression via immunohistochemistry analysis, and WHO grade based on histomorphological assessment of resected tumor tissue by a pathologist."

Answered by AI

What is the safety profile for individuals with MRI results suggestive of meningioma who require surgical intervention?

"Our evaluation at Power places the safety rating for individuals with MRI results indicative of meningioma that necessitate surgery at level 3. This is due to the Phase 4 status, indicating official approval of this intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

2024. "Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06377371.

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