Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
This study is looking at a new way to help surgeons find meningioma (a type of brain tumor) during surgery. Researchers are testing if a special imaging agent called [Cu64]DOTATATE, combined with a device called a Neoprobe, can help surgeons better detect the tumor. You would have a PET/MRI or PET/CT scan with [Cu64]DOTATATE before your surgery, and then the surgeon would use the Neoprobe during the operation. You would also have two more scans after surgery to see how well this method worked. This study aims to see if this approach is practical and helpful for patients aged 18 to 99 who need surgery for a suspected or recurrent meningioma. The study is currently unclear on its recruitment status.
- Study design
- This is a single-center pilot study involving 20 participants. It is an interventional study, meaning participants will receive specific interventions.
- What's involved
- You would undergo a [Cu64]DOTATATE PET/MRI or PET/CT scan before surgery, have radio-guided surgery using a Neoprobe, and then have two more [Cu64]DOTATATE PET/MRI or PET/CT scans after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for up to one year after surgery, with scans at 3 months and 1 year post-operation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jana Ivanidze, MD/PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Preoperative [Cu64]DOTATATE PET SUVAt time of enrollment
preoperative lesion \[Cu64\]DOTATATE PET SUV
- 1st Post-operative [Cu64]DOTATATE PET SUV3 months
6 weeks to 3 months follow up post operative \[Cu64\]DOTATATE PET SUV
- 2nd Post-operative [Cu64]DOTATATE PET SUV1 year
6 months to 12 months follow up post operative \[Cu64\]DOTATATE PET SUV
- MRI Size MeasurementsAt time of enrollment
preoperative size measurements based on Response Assessment in Neuro-Oncology (RANO) guidelines
- GTR vs STR Assessment6 weeks- 3 months
postoperative MRI-based assessment of GTR versus STR by a neuroradiologist, as determined by the presence or absence of nodular dural-based enhancement on post contrast 3D T1-weighted MR imaging and direct comparison to preoperative MRI.
- MRI Progression Assessment6-12 months
follow-up MRI assessment of progression based on RANO guidelines
- Target Lesion Neoprobe CountAt time of enrollment
Neoprobe count of the target lesion prior to resection.
- Subtotal Neoprobe CountAt time of enrollment
Neoprobe count of the subtotally resected tumor or the resection cavity in case of presumed GTR post resection.
- Reference Background Neoprobe CountAt time of enrollment
Neoprobe count of the reference background measured at least 1 cm away from the tumor (measured in at least two locations depending on the operative field)