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

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111588
• Other study ID #: 2018/2243
• Status: Recruiting
• Start date: November 25, 2019
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: Norwegian University of Science and Technology
• Contact: Live Eikenes, PhD
• Phone: 0047 99568081
• Email: live.eikenes[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland universitetssykehus	Bergen
Norway	Universitetssykehus Nord Norge	Tromsø
Norway	St Olavs Hospital	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway, University of Bergen, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy in detecting brain tumor tissue at 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.	Baseline
Secondary	Diagnostic accuracy using dynamic PET	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.	Baseline
Secondary	Differentiation between recurrence and treatment related changes using PET/MRI	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.	4-6 months