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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of PET scans, Ga-68-DOTATATE and Ga-68-DOTATOC, to determine which better detects meningioma, a type of brain tumor. The goal is to identify which scan provides clearer results for doctors to use before surgery. Suitable participants have a suspected meningioma and are preparing for surgery. Participants must be able to lie still during the scan. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in brain tumor detection.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous research has shown that Ga-68-DOTATATE and Ga-68-DOTATOC are safe for people. Studies have found that Ga-68-DOTATATE PET/CT scans are safe and effective for managing meningioma, a type of brain tumor. Another study reported that Ga-68-DOTATOC PET/CT scans are safe and accurate for detecting tumors in children and young adults. Both methods help doctors visualize certain types of tumors by attaching to specific cell receptors. No serious side effects were reported in these studies, indicating that both Ga-68-DOTATATE and Ga-68-DOTATOC are well-tolerated. This trial will compare these two methods to determine which works better for patients with meningioma. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Ga-68-DOTATATE and Ga-68-DOTATOC PET scans for meningioma because they offer a new way to image this type of brain tumor. Unlike standard MRI or CT scans, which can sometimes struggle to provide clear images of meningiomas, these PET scans use radiolabeled tracers that bind specifically to somatostatin receptors, which are often abundant in meningiomas. This targeted approach potentially allows for more accurate detection and characterization of the tumors, which can be crucial for planning surgical interventions. By improving the precision of imaging, these techniques could lead to better treatment outcomes for patients.

What evidence suggests that this trial's treatments could be effective for meningioma?

This trial will compare Ga-68-DOTATATE with Ga-68-DOTATOC PET scans for detecting meningiomas. Research has shown that Ga-68-DOTATATE PET scans effectively spot meningiomas, a type of brain tumor. In one study, Ga-68-DOTATATE PET/MR imaging correctly identified 86.7% of actual cases. This technology aids doctors in planning surgeries and treatments more effectively.

Similarly, studies have found that Ga-68-DOTATOC is also highly effective in detecting meningiomas, making it useful for diagnosis and treatment planning. Both Ga-68-DOTATATE and Ga-68-DOTATOC allow doctors to see the tumors clearly, leading to better treatment decisions and outcomes. ^{2 3 4 5 6}

Who Is on the Research Team?

Jana Ivanidze, MD/PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337622/

Cost-Effectiveness Analysis of 68Ga-DOTATATE PET/MRI in ... A recent diagnostic accuracy analysis of 68Ga-DOTATATE PET/MR imaging in 62 patients with meningiomas demonstrated a sensitivity and specificity of 86.7% and ...

2. redjournal.org redjournal.org/article/S0360-3016(22)00402-3/fulltext

68 Ga-DOTATATE PET: The Future of Meningioma Treatment Potential benefits include improved diagnostic sensitivity, surgical planning, determination of the extent of resection, selection of RT target ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301623080203

A Prospective Registry Study of 68Ga-DOTATATE PET/CT ... This study examined the largest known population of patients with intracranial meningiomas followed by physicians who used 68 Ga-DOTATATE PET/CT-guided therapy.

4. nature.com nature.com/articles/s41598-022-13467-9

DOTATATE PET/MRI analysis in patients with meningioma Further reinforcing its clinical utility, [68Ga]-DOTATATE PET has shown efficacy in predicting progression in non-benign meningioma as well ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rycan.210067

Dynamic 68 Ga-DOTATATE PET/MRI in the Diagnosis and ... Dynamic 68Ga-DOTATATE PET/MRI may also enhance personalized treatment planning in meningioma patients, as well as improve dosimetry analysis in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5698616/

Safety and accuracy of 68Ga-DOTATOC PET/CT in children ... 68 Ga-DOTATOC PET/CT is safe and accurate in children and young adults with solid tumors expressing somatostatin receptor type 2.