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Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases

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ClinicalTrials.gov Identifier: NCT04111588
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : December 2, 2019
Sponsor:
Collaborators:
St. Olavs Hospital
University of Bergen
Haukeland University Hospital
University of Tromso
University Hospital of North Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:

MRI is used in clinical routine for diagnosing brain tumors, but has limitations in identifying tumor grade, true tumor extension and differentiate viable tumor tissue from treatment induced changes and recurrences.

Amino acid PET has demonstrated a great potential for defining true tumor volume, differentiate viable tumor tissue from postoperative changes or radiation necrosis, selection of biopsy site, non-invasive grading of gliomas and for treatment planning and therapy response assessment. By combining PET with MRI, the diagnostic accuracy can improve significantly for these patients. More research is however needed to compare the most promising amino acid PET tracers in patients with glioma, but also to assess the diagnostic value of amino acid PET in patients with different brain metastases, where the knowledge concerning the uptake characteristics is limited.

Three of the most promising amino acid tracers ([11C]-methyl-methionine (11C-MET), [18F] fluoro-ethyl-tyrosin (18F-FET) and anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (18F-FACBC)) will be evaluated in 3 substudies in this project; WP1 Aminoacid PET/MRI in low and high grade glioma; WP2 Role of 11C-MET in high-grade glioma Gamma Knife® radiosurgery; and WP3 Amino acid PET in brain metastasis.

The main aim of the study is to improve diagnostic accuracy, histopathological tissue sampling, delineation of tumor extent and therapy response assessment in gliomas and brain metastases with amino acid PET/MRI.


Condition or disease Intervention/treatment
Brain Neoplasms Other: Diagnostic Amino acid PET/MRI examination

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Glioma

20 low-grade (LGG) and 40 high-grade glioma (HGG) patients will be included from the Department of Neurosurgery at St. Olavs Hospital and the Department of Neurosurgery at the University hospital of North Norway and examined with 18F-FACBC PET/MRI at baseline and 4-6 months after surgery. Furthermore, 10 of the LGG patients and 10 of the HGG patients will be examined with an additional 18F-FET PET/MRI at baseline for comparison with 18F-FACBC.

30 recurrent HGG patients will be recruited from the Department of Neurosurgery and the Department of Oncology at the Haukeland University Hospital. These patients will be examined with 11C-MET PET/MRI at treatment/baseline and 1 month after radiosurgery.

Other: Diagnostic Amino acid PET/MRI examination
Diagnostic Amino acid PET/MRI examination

Brain Metastases
Patients with brain metastases (18F-FACBC: n=20, 18F-FET: n=20 and 11C-MET: n=30) will be included from the Department of Neurosurgery at St. Olavs Hospital, the Department of Neurosurgery at Haukeland University Hospital and the Department of Neurosurgery at the University hospital of North Norway, and examined with amino acid PET/MRI at baseline, 1 month after surgery/stereotactic radiosurgery (St. Olavs Hospital/UNN: Linac, Haukeland University Hospital: Gamma Knife® radiosurgery) and at suspicion of recurrence.
Other: Diagnostic Amino acid PET/MRI examination
Diagnostic Amino acid PET/MRI examination




Primary Outcome Measures :
  1. Diagnostic accuracy in detecting brain tumor tissue at baseline [ Time Frame: Baseline ]
    Diagnostic accuracy, sensitivity, specificity, positive-and negative predictive values of PET, contrast-enhanced MRI (MRICE) and combined PET/MRI will be calculated by comparing images to histopathological results for the large non-localized biopsies as well as to the image-localized biopsies taken prior to resection.


Secondary Outcome Measures :
  1. Diagnostic accuracy using dynamic PET [ Time Frame: Baseline ]
    Dynamic PET will be compared for differentiation between low-grade and high-grade tumors and to study the relationship between the time-activity-curve pattern and histology type.

  2. Differentiation between recurrence and treatment related changes using PET/MRI [ Time Frame: 4-6 months ]
    18F-FACBC uptake (at follow-up), in terms of SUV, TBR, and TAC will be compared to MRI and baseline-PET to evaluate if PET can detect recurrent disease prior to MRI, or if PET can define early treatment response better than MRI.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • 20 low-grade glioma (LGG) patients
  • 40 high-grade glioma (HGG)
  • 30 recurrent HGG patients
  • 70 Patients with brain metastases
Criteria

Inclusion Criteria:

  • Inclusion criteria Glioma (LGG, HGG and recurrent HGG):

    • Planned treatment for WHO grade II-IV diffuse glioma
    • Adult patients (>18 years)
    • Planned tissue sampling for histopathological diagnosis.
    • KPS >60 (able to care for self)

Inclusion criteria Brain Metastasis:

  • Indication of surgery or stereotactic radiosurgery for 1-4 brain metastases
  • Planned surgery: Suspicion of brain metastasis or known diagnosis
  • Stereotactic surgery: Known primary cancer
  • Adult patients (>18 years)
  • Estimated survival at least 3 months after inclusion

Exclusion Criteria:

  • Exclusion criteria (Glioma and Brain Metastasis):

    • Pacemakers or defibrillators not compatible with 3T MRI
    • No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits).
    • Pregnancy (pregnancy test for all women in fertile age when doubt about possible pregnancy exist)
    • Breastfeeding
    • Weight > 120 kg

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): NCT04111588


Contacts
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Contact: Live Eikenes, PhD 0047 99568081 live.eikenes@ntnu.no
Contact: Anna Karlberg, PhD 0047 40489126 anna.karlberg@ntnu.no

Locations
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Norway
Haukeland universitetssykehus Not yet recruiting
Bergen, Norway
Universitetssykehus Nord Norge Not yet recruiting
Tromsø, Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Live Eikenes       live.eikenes@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
University of Bergen
Haukeland University Hospital
University of Tromso
University Hospital of North Norway
Investigators
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Principal Investigator: Live Eikenes, Phd Norwegian University of Science and Technology
Study Director: Øystein Risa Norwegian University for Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT04111588    
Other Study ID Numbers: 2018/2243
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Diagnosis
Magnetic Resonance Imaging
Positron-Emission Tomography
PET-tracer
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases