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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

• 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

Locations
Other Locations
Norway
Haukeland universitetssykehus
NOT_YET_RECRUITING
Bergen
Universitetssykehus Nord Norge
NOT_YET_RECRUITING
Tromsø
St Olavs Hospital
RECRUITING
Trondheim
Contact Information
Primary
Live Eikenes, PhD
live.eikenes@ntnu.no
0047 99568081
Backup
Anna Karlberg, PhD
anna.karlberg@ntnu.no
0047 40489126
Time Frame
Start Date: 2019-11-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 160
Treatments
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.
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.
Sponsors
Collaborators: University Hospital of North Norway, St. Olavs Hospital, University of Bergen, Haukeland University Hospital, University of Tromso
Leads: Norwegian University of Science and Technology

This content was sourced from clinicaltrials.gov