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Radiopharmaceutical

Ga-68-DOTATATE vs. Ga-68-DOTATOC PET Scans for Meningioma

Phase 2
Waitlist Available
Led By Jana Ivanidze, MD/Ph.D
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
No contraindications to either radiotracer
Be older than 18 years old
Must not have
Age less than 18 years
Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 12 months
Awards & highlights

Summary

This trial is comparing two types of PET scans to see which is more effective in diagnosing meningiomas.

Who is the study for?
This trial is for adults who are suspected to have meningioma and are preparing for surgery. They must be able to lie still on a scanner table and not have any reasons they can't receive the radiotracers being tested.Check my eligibility
What is being tested?
The study aims to directly compare two imaging agents, Ga-68-DOTATATE and Ga-68-DOTATOC, using PET/CT or PET/MR scans in patients with meningioma to see which provides better information.See study design
What are the potential side effects?
While the document doesn't list specific side effects, similar diagnostic agents may cause mild irritation at the injection site, nausea, or allergic reactions. Serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no known allergies or reactions to diagnostic dyes or tracers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
Select...
I cannot lay on a scanner table for long due to pain or claustrophobia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Qualitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
Quantitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
Secondary outcome measures
Compare molecular biomarker (EGFR) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (EGFR) results to the maximum SUV ratio of target lesion to cranial blood pool.
Compare molecular biomarker (Ki67) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (Ki67) results to the maximum SUV ratio of target lesion to cranial blood pool.
Compare molecular biomarker (SSTR2 expression) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (SSTR2 expression) results to the maximum SUV ratio of target lesion to cranial blood pool.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with MeningiomaExperimental Treatment2 Interventions
Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for meningioma include surgical resection, radiation therapy, and radiolabeled somatostatin analogs. Radiolabeled somatostatin analogs, such as Ga-68-DOTATATE and Ga-68-DOTATOC, work by binding to somatostatin receptors, which are often overexpressed on meningioma cells. This binding allows for precise PET imaging, enabling better localization and characterization of the tumor. This is crucial for meningioma patients as it aids in accurate diagnosis, treatment planning, and monitoring of disease progression, ultimately improving clinical outcomes.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,319,180 Total Patients Enrolled
2 Trials studying Meningioma
220 Patients Enrolled for Meningioma
Cornell UniversityOTHER
167 Previous Clinical Trials
14,089,974 Total Patients Enrolled
Jana Ivanidze, MD/Ph.DPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Meningioma
200 Patients Enrolled for Meningioma

Media Library

Ga-68-DOTATATE (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04298541 — Phase 2
Meningioma Research Study Groups: Patients with Meningioma
Meningioma Clinical Trial 2023: Ga-68-DOTATATE Highlights & Side Effects. Trial Name: NCT04298541 — Phase 2
Ga-68-DOTATATE (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298541 — Phase 2
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