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

Overseen By Eileen Chang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Age under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

6 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Ga-68-DOTATATE for meningioma?

Research shows that Ga-68-DOTATATE PET scans can help in detecting and planning treatment for meningiomas, especially when combined with MRI, leading to better identification of tumor areas and more precise radiation treatment. This drug has been found to be more sensitive and specific than MRI alone, aiding in the detection of recurrent meningioma and improving treatment outcomes. ^{1 2 3 4 5}

Is Ga-68-DOTATATE or Ga-68-DOTATOC safe for use in humans?

The studies reviewed focus on the use of Ga-68-DOTATATE and Ga-68-DOTATOC for imaging in meningioma treatment planning, but they do not provide specific safety data. However, these agents are commonly used in medical imaging, suggesting they are generally considered safe for human use. ^{1 2 4 6 7}

How is the treatment with Ga-68-DOTATATE and Ga-68-DOTATOC different from other treatments for meningioma?

Ga-68-DOTATATE and Ga-68-DOTATOC are unique because they are used in PET scans to better visualize meningiomas by targeting somatostatin receptors, which are often present in these tumors. This approach helps in more precise radiation treatment planning compared to traditional MRI, potentially leading to smaller radiation volumes and improved detection of tumor areas. ^{1 2 3 4 8}

What is the purpose of this trial?

This trial is evaluating different imaging scans to determine which one is more effective in detecting brain tumors in patients with meningioma. The scans use substances that make the tumors more visible, aiding doctors in their diagnosis.

Research Team

Jana Ivanidze, MD/PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

Inclusion Criteria

I am preparing for surgery with necessary pre-surgery evaluations.

I am an adult suspected to have meningioma.

I have no known allergies or reactions to diagnostic dyes or tracers.

Exclusion Criteria

I am under 18 years old.

I cannot lay on a scanner table for long due to pain or claustrophobia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Comparison

Direct comparison of Ga-68-DOTATATE and Ga-68-DOTATOC PET/CT in patients with meningioma

12 months

Multiple imaging sessions

Surgical Resection and Biomarker Analysis

Patients undergo surgical resection of the lesion and biomarker analysis is performed

12 months

Follow-up

Participants are monitored for safety and effectiveness after imaging and surgical procedures

4 weeks

Treatment Details

Interventions

• Ga-68-DOTATATE
• Ga-68-DOTATOC

Trial Overview 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.

Participant Groups

Group I: Patients with Meningioma Experimental Treatment 2 Interventions

Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Meningiomas: a comparative study of 68Ga-DOTATOC, 68Ga-DOTANOC and 68Ga-DOTATATE for molecular imaging in mice. [2021]

2. India pubmed.ncbi.nlm.nih.gov

The Prognostic Value of Pretreatment Gallium-68 DOTATATE Positron Emission Tomography/Computed Tomography in Irradiated Non-benign Meningioma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Complementary Role of 68Ga-DOTATATE PET/CT in Diagnosis of Recurrent Meningioma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

68Ga-DOTATATE PET-Based Radiation Contouring Creates More Precise Radiation Volumes for Patients With Meningioma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improved Detection of Postoperative Residual Meningioma with [68Ga]Ga-DOTA-TOC PET Imaging Using a High-resolution Research Tomograph PET Scanner. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Prospective Registry Study of 68Ga-DOTATATE PET/CT Incorporation Into Treatment Planning of Intracranial Meningiomas. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Detection of cranial meningiomas: comparison of ⁶⁸Ga-DOTATOC PET/CT and contrast-enhanced MRI. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Potential impact of (68)Ga-DOTATOC PET/CT on stereotactic radiotherapy planning of meningiomas. [2021]