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68Ga-citrate PET/MR Imaging for Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335280
Recruitment Status : Terminated (Low Accrual)
First Posted : November 7, 2017
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
American Brain Tumor Association
Information provided by (Responsible Party):
Susan Chang, University of California, San Francisco

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
Glioma Drug: 68Ga-citrate PET/MR

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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 : February 26, 2019
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : April 24, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335280


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Susan Chang
American Brain Tumor Association
Investigators
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Principal Investigator: Susan Chang, MD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by Susan Chang, University of California, San Francisco:
Informed Consent Form  [PDF] September 26, 2019

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Responsible Party: Susan Chang, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03335280    
Other Study ID Numbers: 181016
NCI-2020-00335 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue