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68Ga-citrate PET/MR Imaging for Glioma

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ClinicalTrials.gov Identifier: NCT03335280
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Evans, University of California, San Francisco

Brief Summary:
This is a prospective, Phase 2, single center, open-label study in adult patients with presumed 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 PET/MR prior to surgery.

Condition or disease Intervention/treatment
Glioma Diagnostic Test: 68Ga-citrate PET/MR

Study Type : Observational
Estimated Enrollment : 40 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 : May 31, 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Positive for PTEN deletion
Confirmed by immunohistochemistry of tissue biopsy
Diagnostic Test: 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
Diagnostic Test: 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. SUVmax [ Time Frame: 1 day ]
    The location and extent of 68Ga-citrate uptake will be compared to both same day 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 ttest between those patients positive for PTEN deletion and those negative for PTEN deletion.



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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:

  • WHO grade 3 or 4 glioma planning to undergo surgery
  • Age >= 18 years
  • Karnofsky performance status of >= 60
  • Ability to understand a written informed consent document, and the willingness to sign it

Cohort A - 20 subjects

  • Positive for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy Cohort B - 20 subjects
  • Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy

Exclusion Criteria:

  • Contraindications to PET imaging (e.g. pregnant or breast-feeding woman)
  • Contraindications to 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


Contacts
Contact: Kenneth Gao, BS 415-353-9437 kenneth.gao@ucsf.edu
Contact: Dora Tao, BS 415-514-6759 dora.tao@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94107
Contact: Kenneth Gao, BS    415-353-9437    kenneth.gao@ucsf.edu   
Contact: Dora Tao, BS    415-514-6759    dora.tao@ucsf.edu   
Principal Investigator: Susan Chang, MD         
Principal Investigator: Michael Evans, PhD         
Sub-Investigator: Spencer Behr, MD         
Sub-Investigator: Mitchel Berger, MD         
Sub-Investigator: Steve Braunstein, MD         
Sub-Investigator: Soonmee Cha, MD         
Sub-Investigator: David Wilson, MD         
Sub-Investigator: Robert Flavell, MD         
Sub-Investigator: Christopher Hess, MD, PhD         
Sub-Investigator: Javier Villanueva-Meyer, MD         
Sub-Investigator: Sarah Nelson, PhD         
Sub-Investigator: Annette Molinaro, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Michael Evans, PhD University of California, San Francisco

Publications:

Responsible Party: Michael Evans, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03335280     History of Changes
Other Study ID Numbers: 15-17319
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action