18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:December 2013
End Date:July 1, 2019

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Evaluating the Impact of 18F-DOPA-PET on Radiotherapy Planning for Newly Diagnosed Gliomas

This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission
tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing
radiation therapy. Comparing results of diagnostic procedures done before and during
radiation therapy may help doctors predict a patient's response to treatment and help plan
the best treatment.

PRIMARY OBJECTIVES:

I. Compare confirmed-progression free survival at 6 months for grade IV MGMT unmethylated
glioma patients after radiation therapy targeting volumes designed with both 18F-DOPA PET and
conventional magnetic resonance (MR) image information with historical controls from Mayo
Clinic Rochester patients, including those treated on North Central Cancer Treatment Group
(NCCTG) clinical trials.

SECONDARY OBJECTIVES:

I. Compare progression free survival at 12 months for grade III patients after radiation
therapy targeting volumes designed with both 18F-DOPA PET and conventional MR image
information with historical controls from Mayo Clinic Rochester patients, including those on
NCCTG clinical trials.

II. Compare patient overall survival after radiation therapy targeting volumes designed with
both 18F-DOPA PET and conventional MR image information with historical controls from Mayo
Clinic Rochester patients, including those on NCCTG clinical trials.

III. Evaluate quality of life after radiotherapy treatment targeting dose escalated volumes
defined to include high 18F-DOPA PET uptake.

IV. Determine acute and late effect toxicity after radiotherapy treatment targeting dose
escalated volumes defined to include high 18F-DOPA PET uptake.

V. Compare confirmed-progression free survival at 12 months for grade IV MGMT methylated
patients after radiation therapy targeting volumes designed with both 18F-DOPA PET and
conventional MR image information with historical controls from Mayo Clinic Rochester
patients, including those on NCCTG clinical trials.

VI. Compare confirmed-progression free survival in grade IV MGMT un-methylated patients with
similar historical controls from Mayo Clinic Rochester patients, including those on NCCTG
clinical trials.

VII. Compare confirmed-progression free survival in grade IV MGMT methylated patients with
similar historical controls from Mayo Clinic Rochester patients, including those on NCCTG
clinical trials.

TERTIARY OBJECTIVES:

I. Compare radiation therapy (RT) treatment volumes defined by MR only with RT treatment
volumes defined with both PET and MR information for grade IV glioma patients.

II. Compare timing of accurate identification of progression defined by 18F-DOPA PET,
perfusion magnetic resonance imaging (pMRI) and conventional MRI for grade IV glioma
patients.

III. Compare patterns of failure after radiation therapy targeting volumes defined with
target volumes designed to with both 18F-DOPA PET and conventional MR image information with
patterns of failure for historical controls from Mayo Clinic Rochester patients, including
those on NCCTG clinical trials.

IV. Compare RT treatment volumes defined by MR only with RT treatment volumes defined with
both PET and MR information for grade III glioma patients.

V. Evaluate intra- and inter-observer variability with vs. without the addition of 18F-DOPA
PET uptake for radiotherapy target volume delineation.

VI. Compare timing of accurate identification of progression defined by 18F-DOPA PET, pMRI
and conventional MRI for grade III glioma patients.

VII. Compare predictive capabilities of 18F-DOPA PET, pMRI and diffusion tensor imaging (DTI)
for localization of recurrences for patients treated with 18F-DOPA PET-guided RT dose
escalation.

OUTLINE:

Patients undergo 18F DOPA-PET, pMRI, and DTI within 14 days before radiation therapy, 3-6
weeks after radiation therapy, and during follow-up. Patients also undergo
intensity-modulated radiation therapy (IMRT) over 30 fractions and receive temozolomide.

After completion of study treatment, patients are followed up periodically for up to 5 years.

Inclusion Criteria:

- Histologically confirmed newly diagnosed grade IV malignant glioma; Note: grade III
patients are no longer being enrolled

- Computed tomography (CT) simulation, immobilization, MRI and PET imaging, treatment
planning, and all follow-up MRI and PET scans to be performed at Mayo Clinic
Rochester; Note: the actual radiation therapy treatments and follow-up other than
imaging can be performed at Mayo Clinic Rochester, Northfield, LaCrosse, Mankato, Eau
Claire, or Albert Lea

- Provide written informed consent

- Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

- Patients diagnosed with anaplastic oligodendroglioma

- Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator,
kidney failure)

- Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's disease, taking
anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from
discontinuance of dopamine agonists); NOTE: other potentially interfering drugs
consist of: amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine,
mazindol, methamphetamine, methylphenidate, norephedrine, phentermine,
phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient
is on any of these drugs, list which ones on the on-study form

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Nadia N. Laack
Phone: 855-776-0015
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mi
from
Rochester, MN
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