Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377371
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-10
Brief Title:
Feasibility of Intraoperative Tracing of Meningioma Using Cu64DOTATATE
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using Cu64DOTATATE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study team hypothesizes that it is feasible to intraoperatively detect tumor following CU64DOTATATE injection using the gamma probe device
Detailed Description:
Objectives
Primary objectives The primary objective of this pilot study is to evaluate the feasibility of intraoperative tumor detection using Cu64DOTATATE The study team further wants to validate the gamma count measurements using pre- and post-operative Positron Emission Tomography PET standardized uptake value SUV
Secondary Objectives To correlate intraoperative tracing findings with from pathology markers World Health Organization grade WHO grade Ki-67 Somatostatin Receptor 2 expression SSTR2A expression Estrogen receptor expression ER expression Progesterone receptor expression PR expression using samples obtained as part of routine surgical care To evaluate the correlation of post resection gamma count with longitudinal PET follow up
Exploratory objectives To establish best practices for integration of intraoperative tumor tracing using the neoprobe into the surgical workflow To determine surgical candidates who will benefit most from intraoperative tracing based on tumor location MRI features etc
Overall Design
This is a single-center prospective observational pilot study to determine the feasibility of using Cu64DOTATATE for intraoperative tumor detection 20 patients diagnosed with meningioma by conventional magnetic resonance imaging MRI who are candidates for surgical resection will be enrolled Enrollment will be facilitated by colleagues in the neurosurgery department also co- investigators on this study with whom the PI has had several years of collaboration and an ongoing referral stream 6pprox 5 patients per week
Patients will subsequently undergo pre-operative Cu64DOTATATE PETMRI 12-24 hours prior to surgery Given that Cu64DOTATATE has a much longer half-life compared to Ga68DOTATATE it is uniquely suited for this application allowing the patient to be injected once with the clinically approved dose undergo immediate Positron Emission tomography scan and magnetic resonance imaging scan PETMRI or Positron Emission tomography scan and computed tomography scan PETCT and undergo resection the following day with sufficient radiotracer in situ for radio-guided surgery RGS
During the operation the neurosurgeon will make a number of measurements using the neoprobe available at our institution and currently in frequent routine clinical use for intraoperative sentinel node detection commonly used for breast cancer melanoma oral cancer
1 After exposing the tumor and immediately before removal tumor counts will be documented with the neoprobe This count will be correlated with preoperative Cu64DOTATATE SUV to evaluate the relationship between radiographic radiotracer uptake and intraoperative radioactivity of the tumor
2 After removing all tumor that can be removed safely the surgeon will grade whether they feel they obtained a gross total resection GTR or whether tumor was left behind subtotal resection STR eg because the surgeon had to leave behind tumor attached to critical structure In case of STR the neoprobe will be used to measure counts in the remaining tumor In case of presumed GTR the neoprobe will be used to measure counts in the resection cavity This second count will be correlated with post-operative Cu64DOTATATE SUV to evaluate the effectiveness of this method in evaluating residual tumor
These steps will not alter the regular course of the surgery in any way Patients will have two follow-up points after the surgery 1 at 6 weeks to 3 months post-op and 2 at 6 months to 12 months post-op Patients will be clinically examined and will undergo repeat Cu64DOTATATE PETMRI or PETCT during these follow up visits as standard of care with radiotracer dosage being funded by the study for the 1st follow up scan and determined standard of care for the 2nd follow up scan
Primary objectives The primary objective of this pilot study is to evaluate the feasibility of intraoperative tumor detection using Cu64DOTATATE The study team further wants to validate the gamma count measurements using pre- and post-operative Positron Emission Tomography PET standardized uptake value SUV
Secondary Objectives To correlate intraoperative tracing findings with from pathology markers World Health Organization grade WHO grade Ki-67 Somatostatin Receptor 2 expression SSTR2A expression Estrogen receptor expression ER expression Progesterone receptor expression PR expression using samples obtained as part of routine surgical care To evaluate the correlation of post resection gamma count with longitudinal PET follow up
Exploratory objectives To establish best practices for integration of intraoperative tumor tracing using the neoprobe into the surgical workflow To determine surgical candidates who will benefit most from intraoperative tracing based on tumor location MRI features etc
Overall Design
This is a single-center prospective observational pilot study to determine the feasibility of using Cu64DOTATATE for intraoperative tumor detection 20 patients diagnosed with meningioma by conventional magnetic resonance imaging MRI who are candidates for surgical resection will be enrolled Enrollment will be facilitated by colleagues in the neurosurgery department also co- investigators on this study with whom the PI has had several years of collaboration and an ongoing referral stream 6pprox 5 patients per week
Patients will subsequently undergo pre-operative Cu64DOTATATE PETMRI 12-24 hours prior to surgery Given that Cu64DOTATATE has a much longer half-life compared to Ga68DOTATATE it is uniquely suited for this application allowing the patient to be injected once with the clinically approved dose undergo immediate Positron Emission tomography scan and magnetic resonance imaging scan PETMRI or Positron Emission tomography scan and computed tomography scan PETCT and undergo resection the following day with sufficient radiotracer in situ for radio-guided surgery RGS
During the operation the neurosurgeon will make a number of measurements using the neoprobe available at our institution and currently in frequent routine clinical use for intraoperative sentinel node detection commonly used for breast cancer melanoma oral cancer
1 After exposing the tumor and immediately before removal tumor counts will be documented with the neoprobe This count will be correlated with preoperative Cu64DOTATATE SUV to evaluate the relationship between radiographic radiotracer uptake and intraoperative radioactivity of the tumor
2 After removing all tumor that can be removed safely the surgeon will grade whether they feel they obtained a gross total resection GTR or whether tumor was left behind subtotal resection STR eg because the surgeon had to leave behind tumor attached to critical structure In case of STR the neoprobe will be used to measure counts in the remaining tumor In case of presumed GTR the neoprobe will be used to measure counts in the resection cavity This second count will be correlated with post-operative Cu64DOTATATE SUV to evaluate the effectiveness of this method in evaluating residual tumor
These steps will not alter the regular course of the surgery in any way Patients will have two follow-up points after the surgery 1 at 6 weeks to 3 months post-op and 2 at 6 months to 12 months post-op Patients will be clinically examined and will undergo repeat Cu64DOTATATE PETMRI or PETCT during these follow up visits as standard of care with radiotracer dosage being funded by the study for the 1st follow up scan and determined standard of care for the 2nd follow up scan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None