Clinical trial · Interventional
18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy
Evaluating the Impact of 18F-DOPA-PET on Radiotherapy Planning for Newly Diagnosed Gliomas
NCT01991977CI-TRIAL-00096675completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion Weighted Imaging | Procedure | — | UNRESOLVED |
| Fluorine F 18 Fluorodopa | Drug | — | UNRESOLVED |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Perfusion Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (PET, pMRI, DTI, IMRT, temozolomide)
- description
- 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 IMRT over 30 fractions and receive temozolomide.
- interventionNames
- Procedure: Diffusion Weighted Imaging
- Drug: Fluorine F 18 Fluorodopa
- Radiation: Intensity-Modulated Radiation Therapy
- Procedure: Perfusion Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Other: Quality-of-Life Assessment
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6)
- timeFrame
- Time from registration to the confirmed disease progression, assessed at 6 months
- description
- The proportion of Grade IV MGMT un-methylated patients that experience confirmed-progression-free survival at 6 months (CPFS6). Progression is defined by any of the following: * ≥25% increase in the sum of products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids * Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events * Any new lesion * Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose. * Failure to return for evaluation due to death or deteriorating condition * Clear progression of non-measurable disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLaack NN, Pafundi D, Anderson SK, Kaufmann T, Lowe V, Hunt C, Vogen D, Yan E, Sarkaria J, Brown P, Kizilbash S, Uhm J, Ruff M, Zakhary M, Zhang Y, Seaberg M, Wan Chan Tseung HS, Kabat B, Kemp B, Brinkmann D. Initial Results of a Phase 2 Trial of 18F-DOPA PET-Guided Dose-Escalated Radiation Therapy for Glioblastoma. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1383-1395. doi: 10.1016/j.ijrobp.2021.03.032. Epub 2021 Mar 23. PMID 33771703