68Ga-citrate PET/MR Imaging for Glioma
April 29, 2020 updated by: Susan Chang
68Ga-citrate PET/MR Imaging for the Evaluation of Glioma in Adults
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults with WHO grade 3 or 4 glioma planning to undergo surgery with availability of immunohistochemistry of tissue
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Positive for PTEN deletion
Confirmed by immunohistochemistry of tissue biopsy
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum standardized uptake value (SUVmax)
Time Frame: 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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan Chang, MD, University of California, San Francisco
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 Major Dates
Study Start (Actual)
February 26, 2019
Primary Completion (Actual)
April 24, 2020
Study Completion (Actual)
April 24, 2020
Study Registration Dates
First Submitted
September 18, 2017
First Submitted That Met QC Criteria
November 2, 2017
First Posted (Actual)
November 7, 2017
Study Record Updates
Last Update Posted (Actual)
May 1, 2020
Last Update Submitted That Met QC Criteria
April 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181016
- NCI-2020-00335 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.