68Ga-citrate PET/MR Imaging for Glioma

Terminated

• Conditions: Glioma
• Interventions: Drug: 68Ga-citrate PET/MR

• Registration Number: NCT03335280
• Lead Sponsor: Susan Chang

Brief Summary

This is a prospective, single center, open-label study in adult patients with presumed World Health Organization (WHO) grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. In some cases, patients will have had biopsy. Study participants will undergo 68Ga-citrate Positron Emission Tomography / magnetic resonance (PET/MR) prior to surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-07
• Study Start: 2019-02-26
• Status Verified: 2020-04
• Primary Completion: 2020-04-24
• Study Completion: 2020-04-24
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• World Health Organization (WHO) grade 3 or 4 glioma planning to undergo surgery
• Age >= 18 yrs.
• Karnofsky performance status of >= 60
• Ability to understand a written informed consent document, and the willingness to sign it.

Cohort A:

• Positive for Phosphatase and Tensin Homolog (PTEN) deletion, confirmed by immunohistochemistry of tissue biopsy

Cohort B:

• Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy

Exclusion Criteria

• Contraindications to Positron Emission Tomography (PET) imaging (e.g. pregnant or breast-feeding woman)
• Contraindications to magnetic resonance (MR) imaging (e.g. pacemakers, metallic implants, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative for PTEN deletion	68Ga-citrate PET/MR	Confirmed by immunohistochemistry of tissue biopsy
Positive for PTEN deletion	68Ga-citrate PET/MR	Confirmed by immunohistochemistry of tissue biopsy

Primary Outcome Measures

Name	Time	Method
Maximum standardized uptake value (SUVmax)	1 day	The location and extent of 68Ga-citrate uptake will be compared to both same day magnetic resonance imaging (MRI) and subsequent pathology. SUVmax will be the outcome of interest and summarized with descriptive measures. SUVmax will be compared via a two-sided two-sample equal-variance t-test between those patients positive for PTEN deletion and those negative for PTEN deletion.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States