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[11C]Acetate PET in Patients With Glioma

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ClinicalTrials.gov Identifier: NCT02986815
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

At each point that the patient will have [11C]-Acetate PET study, this will be compared with standard clinical MR imaging. Abbreviations: XRT - radiation therapy; TMZ - temozolomide (chemotherapy)

Quantitative Image Data Analysis: The [11C]-Acetate uptake in tumor sites from images will be analyzed qualitatively by visual assessment, quantitatively using a standard uptake value (SUV) in the tumor relative to the contralateral normal brain, and the parameters obtained by compartmental modeling of dynamic data.


Condition or disease Intervention/treatment Phase
Glioma Other: [11C]Acetate Brain Imaging Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: [11C]Acetate PET in Patients With Glioma
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [11C]Acetate Brain Imaging
[11C]Acetate will be administered The patient will have one intravenous line placed prior to [11C]Acetate administration. The patient will receive the low-dose CT portion of a PET/CT scan, after which [11C]Acetate will be administered intravenously over approximately 1 min at a dose of 0.3 mCi/kg (maximum 30 mCi) and followed by a saline flush. The injection and imaging procedure will be terminated in any patient who exhibits anaphylaxis, significant dyspnea or chest pain. The administering physician will stay with the patient for at least 15 min after injection and will remain in the Clinical PET Facility through the duration of the imaging procedure.
Other: [11C]Acetate Brain Imaging
Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the patient on the scanner and securing the head in a head restraint, a low dose CT of the brain will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and attenuation correction and it is not considered to be a diagnostic quality CT. Following the completion of the CT, the [11C]Acetate will be administered. A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes.




Primary Outcome Measures :
  1. Visual differences from normal brain in patients with grades 2, 3 or 4 gliomas [ Time Frame: Every 3 months for 24 months ]
    Visual assessment and SUV with standard clinical MR imaging assessment.using T2/FLAIR and gadolinium enhancement.


Secondary Outcome Measures :
  1. Decrease in [11C]Acetate uptake following treatment of grade 2 glioma [ Time Frame: Every 3 months for 24 months ]
    Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate

  2. Decrease in [11C]-acetate uptake following treatment of grade 3 and 4 glioma [ Time Frame: Every 3 months for 24 months ]
    Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate.

  3. Change in [11C]-acetate uptake following treatment at time of progression in grade 3 and 4 gliomas [ Time Frame: Every 3 months for 24 months ]
    Change from baseline in single imaging field over the brain, imaged dynamically for 30 minutes following the start of a 1-min intravenous infusion of [11C]Acetate



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

Inclusion Criteria:

  • Male or female, age 18 and older, of any ethnic group
  • Spanish-speaking patients will be eligible
  • Histological diagnosis of glioma or
  • Brain MR imaging suggestive of a glioma or 2HG > 2mM by MR spectroscopy in patients who have not had a surgical procedure to establish the diagnosis.
  • Karnofsky Performance status > 70%
  • Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
  • Patient able and willing to provide informed consent

Exclusion Criteria:

  • Patient or legal parent/guardian unable to provide informed consent
  • Psychiatric or addictive disorders that preclude obtaining informed consent
  • Karnofsky Performance status < 70%
  • NYHA class III and IV congestive heart failure
  • Unstable angina
  • Pregnant or lactating women
  • Women of childbearing potential who refuse a pregnancy test

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): NCT02986815


Contacts
Contact: Sarah S McNeil, RN 214-822-5232 sarah.mcneil@utsouthwestern.edu
Contact: Robert Bachoo, MD, PhD 214-633-2183 robert.bachoo@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75063
Contact: Sarh McNeil, RN    214-645-8166    sarah.mcneil@utsouthwestern.edu   
Principal Investigator: Robert Bachoo, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02986815     History of Changes
Other Study ID Numbers: STU 052016-034
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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