68Ga-citrate PET/MR Imaging for Glioma

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03335280
• Other study ID #: 181016
• Secondary ID: NCI-2020-00335
• Status: Terminated
• Start date: February 26, 2019
• Est. completion date: April 24, 2020

Study information

• Verified date: April 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 24, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• 68Ga-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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Susan Chang	American Brain Tumor Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum standardized uptake value (SUVmax)	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.	1 day