Phase 2
Completed N=91
18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy
Source: ClinicalTrials.gov NCT01991977 ↗Enrolled (actual)
91
Serious AEs
3.6%
Results posted
Apr 2020
Primary outcomePrimary: Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6) — 0.795 proportion of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6) |
0.795 | — |
| SECONDARY Overall Survival |
16.0; 35.5 | — |
| SECONDARY Progression Free Survival |
8.7; 10.7 | — |
| SECONDARY Quality of Life Evaluated With the M. D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) Questionnaire |
-0.167 | — |
| SECONDARY Number of Patients Experiencing Grade 3+ Treatment-related Toxicities |
17 | — |
| SECONDARY Number of Patients Experiencing Grade 4+ Late Treatment-related Toxicities |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01991977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.