68Ga-citrate PET/MR Imaging for Glioma

68Ga-citrate PET/MR Imaging for the Evaluation of Glioma in Adults

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03335280

Enrollment

Registered

2017-11-07

Start date

2019-02-26

Completion date

2020-04-24

Last updated

2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

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.

Interventions

DRUG68Ga-citrate PET/MR

Study participants will undergo the 68Ga-citrate PET/MR imaging after all screening and baseline assessments have been completed. Patient shall begin imaging between 120 and 360 minutes after the injection of the radiopharmaceutical. Coverage for the scan will extend from the patient's vertex to the neck. The entire imaging study will take roughly 90 minutes.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026