68Ga-citrate PET/MR Imaging for Glioma

Sponsor

Susan Chang (Other)

Overall Status

Terminated

CT.gov ID

NCT03335280

Collaborator

American Brain Tumor Association (Other)

Enrollment

Location

13.9

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma	Drug: 68Ga-citrate PET/MR

Study Design

Study Type:

Observational

Actual Enrollment :

2 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 26, 2019

Actual Primary Completion Date :

Apr 24, 2020

Actual Study Completion Date :

Apr 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Positive for PTEN deletion Confirmed by immunohistochemistry of tissue biopsy	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.
Negative for PTEN deletion Confirmed by immunohistochemistry of tissue biopsy	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.

Arm

Intervention/Treatment

Positive for PTEN deletion

Confirmed by immunohistochemistry of tissue biopsy

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.

Negative for PTEN deletion

Confirmed by immunohistochemistry of tissue biopsy

Drug: 68Ga-citrate PET/MR

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

Susan Chang
American Brain Tumor Association

Investigators

Principal Investigator: Susan Chang, MD, University of California, San Francisco

Study Documents (Full-Text)

Informed Consent Form - Sep 26, 2019

More Information

Publications

None provided.

Responsible Party:

Susan Chang, Principal Investigator, University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT03335280

Other Study ID Numbers:

181016
NCI-2020-00335

First Posted:

Nov 7, 2017

Last Update Posted:

May 1, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glioma

Study Results

No Results Posted as of May 1, 2020