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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special injection, [Cu64]DOTATATE, can help surgeons locate and remove meningioma tumors more effectively during surgery. Meningiomas are brain tumors that often require surgical treatment. The study will employ a gamma probe to detect the tumor during the operation. Suitable candidates include those with a strong suspicion of meningioma based on MRI results or those needing surgery again due to tumor regrowth after a previous operation. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients.

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 is the safety track record for [Cu64]DOTATATE?

Research has shown that [Cu64]DOTATATE is generally safe for people. Studies have found that this compound, used in medical scans, has a strong safety record. Importantly, these studies reported no serious negative reactions, indicating that patients did not experience significant problems from the treatment.

Handling [Cu64]DOTATATE requires care to limit radiation exposure, a standard safety measure for similar treatments. Overall, evidence suggests that [Cu64]DOTATATE is well-tolerated, making it a promising option for those considering participation in a clinical trial with this treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard surgical methods for meningioma, which rely heavily on visual and tactile cues, this new approach uses [Cu64]DOTATATE for radio-guided surgery. This technique allows surgeons to precisely trace and target meningioma tissue during the operation. Researchers are excited about this because it could lead to more accurate removal of tumors, potentially reducing the risk of recurrence and preserving healthy brain tissue. The use of [Cu64]DOTATATE as a tracing agent is a novel feature that enhances surgical precision, making it a significant advancement over traditional surgical techniques.

What evidence suggests that this radio-guided surgery technique is effective for detecting meningioma?

Research has shown that [Cu64]DOTATATE aids surgeons in locating meningiomas, a type of brain tumor, during surgery. In this trial, participants will undergo intraoperative meningioma tracing using [Cu64]DOTATATE. Studies have demonstrated that this compound, when used with PET scans—special imaging tests—enhances tumor visibility. This clarity assists doctors in seeing the tumors more clearly during operations. In past cases, [Cu64]DOTATATE has helped plan both surgery and radiation therapy for patients with meningiomas. The treatment's approval for use in certain imaging tests supports its effectiveness. ^{6 7 8 9 10}

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 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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11933661/

Preoperative PET/MRI and radio-guided surgery using [Cu64 ... This pilot study for the first time demonstrates the feasibility of preoperative PET with in vivo radio-guided surgery in meningiomas.

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/252149

Use of 64 Cu-DOTATATE PET to Guide Treatment of Atypical ... 64 Cu-DOTATATE PET can be used for imaging of atypical meningioma and can help guide radiation therapy planning in de novo and prior treated atypical ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06377371

Study Details | NCT06377371 | Feasibility of Intraoperative ... This is a single-center prospective observational pilot study to determine the feasibility of using [Cu64]DOTATATE for intraoperative tumor detection. 20 ...

4. thejns.org thejns.org/downloadpdf/view/journals/j-neurosurg-case-lessons/9/12/article-CASE24867.pdf

Case Lessons | Journal of Neurosurgery This study demonstrates the potential of radio-guided meningioma resection, in conjunction with preoperative [Cu64]DOTATATE PET/. MRI, in ...

5. mdpi.com mdpi.com/2075-1729/15/4/617

An Update on DOTA-Peptides PET Imaging and Potential ... The results of these studies suggest that 68 Ga-DOTATATE PET/MR imaging is a cost-effective adjunct for planning postoperative radiation therapy in meningioma ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/copper-cu-64-dotatate-intravenous-route/description/drg-20502439

Copper cu 64 dotatate (intravenous route) - Side effects & ... Copper Cu 64 dotatate injection is used with a PET scan (positron emission tomography) for localization of somatostatin receptor positive neuroendocrine tumors ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12028461/

An Update on DOTA-Peptides PET Imaging and Potential ... The objective of this study is to evaluate the safety and benefits of these strategies based on the latest findings. Keywords: PET, meningioma, ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/213227s000lbl.pdf

Detectnet (copper Cu 64 dotatate injection), for intravenous use Handle Detectnet with appropriate safety measures to minimize radiation exposure [see Warnings and. Precautions (5.1)]. Use waterproof gloves, effective ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11631075/

Radioligand therapies in meningioma: Evidence and future ... One case report of [177Lu]Lu-DOTATATE treatment in meningioma showed improved tumor uptake compared to intravenous radionuclide treatment. Another ...

10. jnm.snmjournals.org jnm.snmjournals.org/content/61/6/890

64 Cu-DOTATATE PET/CT for Imaging Patients with ... The safety profile of 64Cu-DOTATATE proved excellent in our study, with no serious adverse events or adverse events related to 64Cu-DOTATATE.