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18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning For a Short Course of Proton Beam Radiation Therapy

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ClinicalTrials.gov Identifier: NCT03778294
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
This phase II trial studies how well fluorodopa F 18-positron emission tomography/magnetic resonance imaging scan (18F-DOPA-PET/MRI) works in imaging elderly patients with newly diagnosed grade IV malignant glioma or glioblastoma during planning for a short course of proton beam radiation therapy. 18F-DOPA is a chemical tracer that highlights certain cells during imaging. PET scan, is a metabolic imaging technique which takes advantage of how tumor cells take up nutrients differently than normal tissue. MRI scans are used to guide radiation therapy for most brain tumors. Hypofractionated proton beam therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Using 18FDOPA-PET scans along with MRI scans may be able to provide the radiation doctor with information on tumor tissue versus normal, healthy tissue and may help the doctor more accurately plan the radiation treatment.

Condition or disease Intervention/treatment Phase
Glioblastoma Malignant Glioma Procedure: Computed Tomography Other: Fluorodopa F 18 Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Drug: Temozolomide Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Compare overall survival at 12 months for grade IV glioma patients after radiation therapy targeting volumes designed with both 18F-DOPA-PET and conventional magnetic resonance (MR) image (or PET/computed tomography [CT]) information with historical controls.

SECONDARY OBJECTIVES:

I. Compare progression free survival at 12 months after radiation therapy targeting volumes designed with both 18F-DOPA-PET and conventional MR image information with historical controls.

II. Determine acute and late effect toxicity after hypofractionated proton beam radiotherapy treatment including areas of high 18F-DOPA-PET uptake (T/N > 2.0).

CORRELATIVE RESEARCH OBJECTIVES:

I. Compare radiotherapy (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 differences in RT volumes identified using biopsy-validated thresholds as highly aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume (relCBV) from perfusion MRI (pMRI) as well as differences in RT volumes identified using biopsy-validated thresholds as tumor extent comparing 18F-DOPA uptake and diffusion maps from diffusion tensor imaging (DTI) will be evaluated.

III. Evaluate quality of life after radiotherapy using European Organization for Research and Treatment of Cancer (EORTC) questionnaires compared with historical controls from Keim-Guibert et al.

IV. Compare differences in proton radiation planning utilizing radiobiologic modeling/evaluation techniques performed at Mayo Clinic Rochester to linear energy transfer distribution evaluation at Mayo Clinic Arizona.

OUTLINE:

Patients receive 18F-DOPA intravenously (IV) and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning course 2, patients receive standard of care temozolomide on days 1-5. Courses with temozolomide repeat every 28 days for up to 7 courses in the in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 1 year, and then periodically for up to 5 years.


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Study Type : Interventional
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients With Newly Diagnosed Glioblastoma
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : November 26, 2021
Estimated Study Completion Date : November 26, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (18F-DOPA, PET/MRI, PET/CT, temozolomide)
Patients receive 18F-DOPA IV and undergo PET/MRI or PET/CT imaging scan. Patients then receive proton beam radiotherapy over 5 or 10 consecutive days excluding weekend and standard of care temozolomide on days 1-7 or 1-14. Beginning course 2, patients receive standard of care temozolomide on days 1-5. Courses with temozolomide repeat every 28 days for up to 7 courses in the in the absence of disease progression or unacceptable toxicity.
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Other: Fluorodopa F 18
Given IV
Other Name: 18F-FDOPA

Procedure: Magnetic Resonance Imaging
Undergo PET/MRI
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Positron Emission Tomography
Undergo PET/CT or PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

Radiation: Proton Beam Radiation Therapy
Receive proton beam RT
Other Names:
  • PBRT
  • Proton Radiation Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Drug: Temozolomide
will receive concurrent chemotherapy, temozolomide
Other Names:
  • CCRG-81045
  • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
  • M & B 39831
  • M and B 39831
  • Methazolastone
  • RP-46161
  • SCH 52365
  • Temcad
  • Temodal
  • Temodar
  • Temomedac




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Time from registration to death due to any cause, assessed up to 12 months ]
    The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: At 12 months after radiation therapy ]
    The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated utilizing exact binomial methodology.

  2. Progression Free Survival [ Time Frame: Time from registration to the earliest date documenting disease progression, assessed up to 5 years ]
    The distribution of progression free survival times groups will be estimated using the method of Kaplan-Meier (1958).

  3. Incidence of adverse events (AEs) [ Time Frame: Up to 5 years post treatment ]
    The rate of acute and late treatment-related toxicities for newly diagnosed high-grade glioma patients treated with fluorodopa F 18-positron emission tomography (18F-DOPA PET) image-guided hypofractionated proton beam therapy will be determined, with acute radiotherapy (RT) toxicities graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.


Other Outcome Measures:
  1. Radiotherapy (RT) treatment volumes [ Time Frame: Up to 5 years post treatment ]
    Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance (MR) only and treatment volumes defined with both positron emission tomography (PET) and MR information.

  2. Quality of life (QOL) [ Time Frame: Up to 5 years post treatment ]
    QOL surveys will be compared to data from historical controls. Quality of life will be assessed at baseline and at each magnetic resonance imaging (MRI) evaluation (up to 6 evaluations). QOL will be measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30.

  3. Differences in proton radiation planning [ Time Frame: Up to 5 years post treatment ]
    Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between proton plan metrics based off the two modeling/evaluation techniques.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed newly diagnosed grade IV malignant glioma
  • Planned radiation treatments at Mayo Clinic Arizona or Mayo Clinic Rochester
  • Willing to sign release of information for any radiation and/or follow-up records
  • Provide informed written consent
  • Patients with estimated glomerular filtration rate (eGFR) >= 60 mg/min/1.72 m^2
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

Exclusion Criteria:

  • Patients diagnosed with grades I-III glioma
  • Currently on avastin at time of treatment
  • 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 antidopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)

    • NOTE: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, 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
  • Pregnant women, nursing women, or men or women of childbearing potential who are unwilling to employ adequate contraception.

    • NOTE: All women enrolled in this study will be age 70 or over, and at the determination of the PI, will not be of childbearing potential. If the radiology department requires a pregnancy test before administering the 18FDOPA injection, they may perform one per their standard of care

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): NCT03778294


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Sujay A. Vora         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials N. Referral Office    855-776-0015      
Principal Investigator: Nadia N. Laack         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sujay Vora Mayo Clinic

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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03778294     History of Changes
Other Study ID Numbers: MC1774
NCI-2018-02800 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1774 ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Glioblastoma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents