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Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

ConditionMeningioma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorWeill Medical College of Cornell University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

High suspicion of meningioma necessitating surgical resection based on conventional MRI criteria, or diagnosis of meningioma based on pathology reports from prior resection with radiographic findings of suspected recurrent or residual tumor necessitating repeat surgery.

Disqualifiers

Pregnant or breastfeeding

Patients undergoing endoscopic endonasal resection, eyebrow incision surgery, or any surgical procedure in which the neoprobe cannot be employed

Patients with hypersensitivity to somatostatin analogs

Patients with contraindications to conventional MRI

Trial design

Design model

Single group

Treatments tested in this trial

  • Brain Imaging with [Cu64]DOTATATE

    Diagnostic test

    Patients will undergo a \[Cu64\]DOTATATE PET/MRI or PET/CT before undergoing radio- guided surgery. Patients will undergo another \[Cu64\]DOTATATE PET/MRI or PET/CT 6 weeks- 3 months after their surgery, and 6 months- 12 months after surgery.

  • Radio-guided Surgery With Neoprobe Utilization

    Procedure/Surgery

    After the subjects undergo the preoperative \[Cu64\]DOTATATE PET/MRI, subjects will undergo radio-guided surgery in which the surgeon will utilize a standard intraoperative gamma probe (Neoprobe Gamma Detection System ®) to assess primary/residual tumor detection.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patients with MRI findings compatible with meningioma who have an indication for surgeryExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Preoperative [Cu64]DOTATATE PET SUV

preoperative lesion \[Cu64\]DOTATATE PET SUV

Time frame
At time of enrollment
2

1st Post-operative [Cu64]DOTATATE PET SUV

6 weeks to 3 months follow up post operative \[Cu64\]DOTATATE PET SUV

Time frame
3 months
3

2nd Post-operative [Cu64]DOTATATE PET SUV

6 months to 12 months follow up post operative \[Cu64\]DOTATATE PET SUV

Time frame
1 year
4

MRI Size Measurements

preoperative size measurements based on Response Assessment in Neuro-Oncology (RANO) guidelines

Time frame
At time of enrollment

Secondary outcomes

1

SSTR2 expression

immunohistochemistry analysis of SSTR2 expression in the resected tumor

Time frame
At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).
2

WHO grade

determined histomorphologically based on pathologist's assessment of resected tumor tissue.

Time frame
At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).
3

Ki67 Proliferation Index

Ki67 Proliferation Index (percentage of positively stained tumor cells among the total number of malignant cells assessed).

Time frame
At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).
4

ER/PR expression

determined based on pathologist's assessment of resected tumor tissue.

Time frame
At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

Curium US LLC

Collaborator

Source ClinicalTrials.gov
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