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出境医 / 临床实验 / 18F-Fluciclovine PET and Multiparametric MR Imaging

18F-Fluciclovine PET and Multiparametric MR Imaging

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Warren Boling, MD Loma Linda University Medical Center
Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE August 24, 2020
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • 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.
  • 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.
  • 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.
  • Biopsy and pathology [ Time Frame: 2 years ]
    Confirmation of tumor vs treatment-induced necrosis in spatially registered areas of interest will be performed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-Fluciclovine PET and Multiparametric MR Imaging
Official Title  ICMJE Differentiating Brain Tumor Recurrence From Treatment-Induced Necrosis Using 18F-Fluciclovine (Anti-18f-facbc) PET and Multiparametric MR Imaging
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Brain Tumor, Recurrent, Adult
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Drug: PET/CT with F-Fluciclovine (Axumin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Warren Boling, MD 909-558-4419 wboling@llu.edu
Contact: Brenda Bartnik-Olson, PhD 909-558-4000 ext 47809 BBartnik@llu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925675
Other Study ID Numbers  ICMJE 5180277
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Warren Boling, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Blue Earth Diagnostics
Investigators  ICMJE
Principal Investigator: Warren Boling, MD Loma Linda University Medical Center
PRS Account Loma Linda University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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