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18F-Fluciclovine PET and Multiparametric MR Imaging

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ClinicalTrials.gov Identifier: NCT03925675
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : September 2, 2020
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
Warren Boling, Loma Linda University

Brief Summary:
The purpose of the study is to investigate the use of the investigational agent Axumin (fluciclovine-F18) with PET/CT imaging in combination with standard MR imaging to detect remaining or recurrent brain tumor.

Condition or disease Intervention/treatment Phase
Brain Tumor, Recurrent, Adult Drug: PET/CT with F-Fluciclovine (Axumin) Phase 2

Detailed Description:

Methods:

Patients with recurrent enhancing mass on MRI in the side of a diagnosed and treated high grade glioma or metastatic brain tumor and consenting to study protocol will undergo 18F-Fluciclovine PET/CT imaging once prior to surgery for brain tumor recurrence. Surgery for recurrent brain tumor will follow standard of care treatment that includes either biopsy of the region or interest or as complete as possible tumor resection followed by histopathological analysis. Outcome evaluation will be analysis of tumor histology and imaging results, comparison of MRI, MRSI, and 18F-Fluciclovine imaging and relationship of imaging findings with histopathology and anatomical location of recurrent tumor.

Study Objectives

  1. In this study, we will investigate the potential of 18F-fluciclovine to aid the visualization of residual or recurrent gliomas as depicted by 18F-Fluciclovine PET imaging compared to standard MRI sequences [T1 weighted imaging (T1WI) with contrast, diffusion weighted imaging (DWI), perfusion weighted imaging (PWI), T2 weighted fluid attenuated inversion recovery (T2 FLAIR)] using 3D image fusion.
  2. To assess the residual or recurrent of glioma as depicted by 3D short echo time MR spectroscopic imaging (MRSI) using metabolic tumor markers such as elevated choline, myo-Inositol and lipids and reduced N-acetyl-aspartate (NAA) compared to standard MRI sequences (T1WI with contrast, PWI, T2 FLAIR) using 3D image fusion before neurosurgical intervention.
  3. To spatially register the residual or recurrent glioma as depicted by 18F-Fluciclovine PET imaging with MR T1WI, DWI, PWI, and 3D MRSI to a) quantitate (SUVmax, SUVmean, ADCmean, rCBV, Cho, NAA, lipids, Cho/Cr, Cho/NAA) and correlate areas of PET+, T1WI+ and MRSI+ areas and b) characterize different metabolic profiles measured with MRSI in areas of glioma infiltration depicted by PET imaging and MRI.
  4. Biopsy and pathology confirmation of tumor vs treatment-induced necrosis in spatially registered areas of interest will be performed.

Safety analysis Although 18F-Axumin™ is an FDA approved PET imaging agent for biological recurrent prostate cancer with extensive safety and toxicity data already documented, all patients will be monitored closely for adverse reactions after administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Subject who agree to participate in this study prior to surgery and sign the consent document, will have the following procedures done:

  1. Axumin (fluciclovine-F18) PET/CT scan will be done to evaluate possible recurrence to help differentiate scar (fake recurrence) from true tumor recurrence, which could be at any time point after initial surgery.
  2. Standard of care imaging surveillance will be done after initial tumor surgery
  3. Standard of care surgery will include the removal of the tumor.

Tumor sample will then be analyzed and compared to the imaging (comparison of MRI, MRSI, and Axumin (fluciclovine-F18) imaging) results to determine an accurate diagnosis and location of tumor in the body.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Differentiating Brain Tumor Recurrence From Treatment-Induced Necrosis Using 18F-Fluciclovine (Anti-18f-facbc) PET and Multiparametric MR Imaging
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Axumin (fluciclovine-F18) PET/CT scan
Axumin (fluciclovine-F18) PET/CT scan to evaluate possible glioma recurrence to help differentiate scar (fake recurrence) from true tumor recurrence
Drug: PET/CT with F-Fluciclovine (Axumin)
Comparison between PET/CT, MRI / MRS imaging, and biopsy histopathology. Data from each modality will be analyzed separately as described above to determine tumor recurrence and/or presence of radiation changes. Different metabolic profiles measured in areas of imaging changes and depicted by PET imaging will be characterized. Biopsy locations from stereotactic MRI data will be co-localized with PET/CT and MRSI to correlate biopsy histopathology with MRI+, MRSI+ and PET+ lesion data.
Other Name: Axumin




Primary Outcome Measures :
  1. 18F-Fluciclovine [ Time Frame: 2 years ]
    Investigate the potential of 18F-fluciclovine to aid the visualization of residual or recurrent gliomas as depicted by 18F-Fluciclovine PET imaging compared to standard MRI sequences [T1 weighted imaging (T1WI) with contrast, diffusion weighted imaging (DWI), perfusion weighted imaging (PWI), T2 weighted fluid attenuated inversion recovery (T2 FLAIR)] using 3D image fusion.

  2. 3D short echo time MR spectroscopic imaging (MRSI) [ Time Frame: 2 years ]
    Using metabolic tumor markers such as elevated choline, myo-Inositol and lipids and reduced N-acetyl-aspartate (NAA) compared to standard MRI sequences (T1WI with contrast, PWI, T2 FLAIR) using 3D image fusion before neurosurgical intervention.

  3. 18F-Fluciclovine PET imaging with MR T1WI, DWI, PWI, and 3D MRSI [ Time Frame: 2 years ]
    Quantitate (SUVmax, SUVmean, ADCmean, rCBV, Cho, NAA, lipids, Cho/Cr, Cho/NAA) and correlate areas of PET+, T1WI+ and MRSI+ areas and b) characterize different metabolic profiles measured with MRSI in areas of glioma infiltration depicted by PET imaging and MRI.

  4. Biopsy and pathology [ Time Frame: 2 years ]
    Confirmation of tumor vs treatment-induced necrosis in spatially registered areas of interest will be performed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with prior histological confirmation of glioma or metastatic brain tumor evaluated for tumor recurrence or radiation changes after initial treatment of surgery, external beam radiation and / or chemotherapy with temozolamide.
  2. Male and female
  3. Ages 18 or greater

Exclusion Criteria:

  1. Patient diagnosis with glioma or metastatic brain tumor but prior to surgery, external beam radiation and /or chemotherapy
  2. Women who were pregnant, breast feeding, or possibly pregnant.
  3. Patients with hepatic or renal dysfunction.
  4. Patients with MRI contraindications (i.e. pacemakers, non-MR compatible devices).
  5. Patients with a history of drug hypersensitivity to 18F-Fluciclovine.

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): NCT03925675


Contacts
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Contact: Warren Boling, MD 909-558-4419 wboling@llu.edu
Contact: Brenda Bartnik-Olson, PhD 909-558-4000 ext 47809 BBartnik@llu.edu

Locations
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United States, California
Loma Linda University Cancer Center Recruiting
Loma Linda, California, United States, 92354
Contact: Warren Boling, MD    909-558-4419    wboling@llu.edu   
Contact: Barbara Holshouser, PhD    909-558-4000 ext 47809    bholshouser@llu.edu   
Sponsors and Collaborators
Loma Linda University
Blue Earth Diagnostics
Investigators
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Principal Investigator: Warren Boling, MD Loma Linda University Medical Center
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Responsible Party: Warren Boling, Primary Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT03925675    
Other Study ID Numbers: 5180277
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases