Radio-guided Surgery for Meningioma

Overseen By Alexis Watson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must not be taking: Somatostatin analogs

Disqualifiers: Pregnancy, Breastfeeding, Cranial radiation, 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: 4

20 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. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment [Cu64]DOTATATE for meningioma?

Research on similar treatments like 68Ga-DOTATATE shows that it can improve treatment planning for meningiomas by providing more precise imaging, which helps in targeting radiation therapy more effectively. Additionally, studies on 177Lu-DOTATATE, another related treatment, have shown promising results in prolonging progression-free survival in certain types of meningiomas. ^{1 2 3 4 5}

Is radio-guided surgery using [Cu64]DOTATATE safe for humans?

Research on similar treatments like [68Ga]-DOTATATE and 177Lu-HA-DOTATATE for meningiomas shows that they are generally safe, with no unexpected adverse events reported in studies. These treatments have been used safely in patients, suggesting that radio-guided surgery using [Cu64]DOTATATE may also be safe. ^{1 3 6 7 8}

How is the drug [Cu64]DOTATATE unique for treating meningioma?

The drug [Cu64]DOTATATE is unique for treating meningioma because it involves radio-guided surgery using a novel technique that can detect very small tumor samples with low radiopharmaceutical activity, potentially improving precision in tumor removal. ^{1 2 9 10 11}

What is the purpose of this trial?

The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device.

Research Team

Jana Ivanidze, MD/PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

Inclusion Criteria

I have a meningioma diagnosis and need another surgery for a suspected return or leftover tumor.

I am likely to have a brain tumor that needs surgery, as seen on an MRI.

Exclusion Criteria

Patients with contraindications to conventional MRI

Patients currently enrolled in other therapeutic clinical trials related to meningioma

I have had radiation therapy to my brain before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Imaging

Participants undergo pre-operative [Cu64]DOTATATE PET/MRI 12-24 hours prior to surgery

1 day

1 visit (in-person)

Surgery and Intraoperative Tracing

Intraoperative tumor detection using [Cu64]DOTATATE and neoprobe measurements during surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up PET/MRI or PET/CT scans

6-12 months

2 visits (in-person)

Treatment Details

Interventions

• [Cu64]DOTATATE

Trial Overview 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.

Participant Groups

Group I: Patients with MRI findings compatible with meningioma who have an indication for surgery Experimental Treatment 2 Interventions

A diagnostic intervention in which patients will undergo intraoperative meningioma tracing using \[Cu64\]DOTATATE.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Curium US LLC

Industry Sponsor

Trials

6

Recruited

1,000+

Findings from Research

In a study of 8 patients with recurrent WHO grade II meningiomas treated with 177Lu-DOTATATE, the progression-free survival at 6 months (PFS-6) was an impressive 85.7%, indicating that this treatment can be effective for refractory cases.

When compared to other studies, SSTR-targeted peptide receptor radionuclide therapy (PRRT) showed a PFS-6 of 89.7% for WHO grade I meningiomas and 57.1% for WHO grade II, suggesting that while effective for lower-grade tumors, it may not be suitable for the most aggressive forms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatostatin Receptor Theranostics for Refractory Meningiomas. Salgues, B., Graillon, T., Horowitz, T., et al.[2022]

In a study of 20 patients with meningiomas, [68Ga]-DOTATATE PET/MRI successfully confirmed recurrent tumors in 85% of cases, demonstrating its effectiveness in distinguishing between tumor recurrence and post-treatment changes.

The novel quantitative analysis approach used in this study showed a significant difference in uptake values between meningiomas and post-treatment changes, suggesting that [68Ga]-DOTATATE PET/MRI could enhance diagnostic accuracy and treatment planning for meningioma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gallium-68 DOTATATE PET in the Evaluation of Intracranial Meningiomas. Ivanidze, J., Roytman, M., Lin, E., et al.[2020]

In a study of 50 patients with meningiomas treated with cobalt-60 gamma knife stereotactic radiosurgery, the 2-year tumor control rate was an impressive 96%, indicating high efficacy of this treatment.

Stereotactic radiosurgery was found to be a safe and effective option for patients with symptomatic meningiomas, especially for those who were not suitable candidates for surgical resection due to age or medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamma knife radiosurgery of meningiomas. Kondziolka, D., Lunsford, LD., Coffey, RJ., et al.[2018]

References

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

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

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

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

3. England pubmed.ncbi.nlm.nih.gov

68Gallium-DOTATATE PET in meningioma: A reliable predictor of tumor growth rate? [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Somatostatin Receptor Theranostics for Refractory Meningiomas. [2022]

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

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

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

Gallium-68 DOTATATE PET in the Evaluation of Intracranial Meningiomas. [2020]

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

Intraarterial Administration Boosts 177Lu-HA-DOTATATE Accumulation in Salvage Meningioma Patients. [2022]

8. England pubmed.ncbi.nlm.nih.gov

[68Ga]-DOTATATE PET/MRI as an adjunct imaging modality for radiation treatment planning of meningiomas. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

The β- radio-guided surgery: Method to estimate the minimum injectable activity from ex-vivo test. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Gamma knife radiosurgery of meningiomas. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Gamma knife robotic microradiosurgery for benign skull base meningiomas: tumor shrinkage may depend on the amount of radiation energy delivered per lesion volume (unit energy). [2016]