Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02986815 |
| Other study ID # |
STU 052016-034 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 24, 2017 |
| Est. completion date |
May 5, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1. [11C]Acetate Administration [11C]Acetate will be administered in the Clinical PET Facility
located on the 2nd floor of the Clements Imaging Building at UT Southwestern. Upon arrival,
the patient will have an opportunity to have questions answered regarding the procedure. 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. All adverse events
occurring post [11C]Acetate infusion will be recorded within a 24-hour period. The adverse
events to be specifically monitored during the infusion include localized discomfort at the
IV injection site, pain, respiratory difficulties, flushing, dizziness, pruritus/rash, and
any other symptoms that could be secondary to an anaphylactic reaction. The subject will be
instructed to report any subjective symptoms or sensory changes noted.
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 as described in Section VI.F.3.b.
A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes. From the list
mode data a flow image series will be constructed as follows:
- 12 frames x 10 seconds each (out to 2 minutes post-injection)
- then 6 frames x 30 seconds each
- then 1 frame x 60 seconds each
A second series will be -reconstructed to demonstrate dynamic brain regional metabolism as
follows:
- 12 frames x 10 seconds each (out to 2 minutes post-injection)
- then 8 frames x 30 seconds each (from 2 to 6 minutes)
- then 4 frames x 60 seconds each (from 6 to 10 minutes)
- then 2 frames of 300 seconds each (from 10 to 20 minutes)
- then 1 frame of 600 seconds (from 20 to 30 minutes) Reconstructions will be performed
with a 128 x 128 image matrix using 3D OSEM (4 iterations, 21 subsets) and a 3 mm
Gaussian filter.
3. Study Procedures and Schedule of Events:
1. Initial visits prior to [11C]Acetate PET/CT:
Patients who are identified as potential candidates for the study will be
approached to explain the study and to obtain their written informed consent to be
enrolled in the protocol. The following additional patient data will be obtained:
histologic diagnosis (if a surgical procedure has been carried out), IDH mutational
status, age at radiologic diagnosis, weight, full medical and neurological history
and physical exam. Correlative imaging will be performed using MR brain, with and
without gadolinium, within 14 days prior to enrollment. In addition, when
available, 2-hydroxyglutarate (2HG) MR spectroscopy will be available for review
and determination of 2HG concentration. For patients referred from outside UTSW and
Parkland hospital, patient records and imaging will be reviewed to determine
eligibility for the study and to obtain baseline comparative imaging scans.
2. Day of baseline and follow up [11C]Acetate scans:
[11C]Acetate PET/CT scan performed at baseline and at the time of clinical follow
up; 3 months for grade 2 glioma patients on standard follow up, 2-3 months after
treatment for patients being imaged pre- and post-treatment. The patient will be
positioned supine in the PET/CT scanner for a dynamic scan over the brain. Patients
will have two intravenous lines placed, one in each arm. [11C]Acetate PET/CT will
be performed using the standard dose of 0.3 mCi/kg up to a maximum of 30mCi for
[11C]Acetate. A single imaging field over the brain will be imaged dynamically for
30 min following the start of a 1-min intravenous infusion of [11C]Acetate, as
described in Section VI.F.2.
4. General Concomitant Medication and Supportive Care Guidelines Any adverse
effects, related or non-related to the injection of [11C]Acetate, will be treated
as clinically indicated with no study-related restrictions.
5. Duration of Therapy and Follow-up: This is an observational study and patients
will remain on study for the duration of their clinical follow up, as determined by
their treating physician. [11C]Acetate PET scan timing will be determined based on
their individual clinical course.
