RECRUITING

Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

Quick Facts

Study Start:2024-09-11

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06377371

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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 * Patients with prior history of cranial radiation therapy * Patients currently enrolled in other therapeutic clinical trials related to meningioma will be excluded

Inclusion Criteria

Exclusion Criteria

* 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.

* 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
* Patients with prior history of cranial radiation therapy
* Patients currently enrolled in other therapeutic clinical trials related to meningioma will be excluded

Contacts and Locations

Study Contact

Jana Ivanidze, MD/PhD

CONTACT

212-746-4587

jai9018@med.cornell.edu

Alexis Watson

CONTACT

646-962-2347

alw4020@med.cornell.edu

Principal Investigator

Jana Ivanidze, MD/PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

New York-Presbyterian/Weill Cornell Medical Center

New York, New York, 10021

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Jana Ivanidze, MD/PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11

Study Completion Date2025-01

Study Record Updates

Study Start Date2024-09-11

Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

Meningioma