Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR
Primary Purpose
Brain Metastases, Cancer, Gliomas
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
F18 Fluciclovine
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Brain Metastases
Eligibility Criteria
Inclusion Criteria
- An adult patient with suspected or pathology-proven central nervous system neoplasm.
- MRI of the brain, positive for at least one intra-axial lesion greater than 5 mm.
Exclusion Criteria
- Contraindication to MR imaging.
- Known allergy to gadolinium-based contrast agents.
- Renal failure as defined by a GFR less than 30 or the use of hemodialysis.
- Pregnant.
- Patients less than 18 years of age will be excluded.
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
F18 Fluciclovine
Arm Description
radioactive imaging agent help researchers better "see" how the disease is responding to laser interstitial thermal therapy (LITT)
Outcomes
Primary Outcome Measures
To establish the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT.
Secondary Outcome Measures
Full Information
NCT ID
NCT05054400
First Posted
September 3, 2021
Last Updated
August 30, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05054400
Brief Title
Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR
Official Title
Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
0 participant accrual
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
August 29, 2023 (Actual)
Study Completion Date
August 29, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT. We hypothesize that imaging with F18 Fluciclovine will be superior to anatomic MR imaging in lesion volume assessment before treatment and that residual F18 Fluciclovine defined tumor will predict local post-LITT disease recurrence.
Detailed Description
Primary Objectives
-To estimate the accuracy of F18 Fluciclovine PET MR for laser interstitial thermal therapy (LITT) treatment response assessment as determined by T1 post-contrast MR brain imaging.
Secondary Objectives
To assess changes in F18 Fluciclovine defined disease with LITT.
To assess the volume change of the idealized quantitative T1 values of lesions compared -To assess the volume change of idealized quantitative T2 values of lesions compared to -Chemical Exchange Saturation Transfer (CEST) MRI - To assess the ability of CEST imaging to differentiate treatment change from residual disease in brain malignancy following LITT.
Multiple B Value Diffusion Imaging (Adv Diff) - To assess whether Adv Diff can differentiate treatment changes from residual disease in brain malignancy following LITT.
Gradient- and Spin-Echo DSC perfusion imaging - To assess whether GESE DSC improves differentiation of treatment change from residual disease in brain malignancy -Adv ASL perfusion imaging - To assess the ability of Adv ASL to differentiate treatment change from residual disease in brain malignancy following radiation therapy.
Exploratory Objectives
To assess the relationship between post-LITT enhancing brain tissue and F18 -To assess changes in regional homogeneity (ReHo) values after LITT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases, Cancer, Gliomas, Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F18 Fluciclovine
Arm Type
Other
Arm Description
radioactive imaging agent help researchers better "see" how the disease is responding to laser interstitial thermal therapy (LITT)
Intervention Type
Drug
Intervention Name(s)
F18 Fluciclovine
Intervention Description
Given by IV
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
To establish the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
An adult patient with suspected or pathology-proven central nervous system neoplasm.
MRI of the brain, positive for at least one intra-axial lesion greater than 5 mm.
Exclusion Criteria
Contraindication to MR imaging.
Known allergy to gadolinium-based contrast agents.
Renal failure as defined by a GFR less than 30 or the use of hemodialysis.
Pregnant.
Patients less than 18 years of age will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Johnson
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77031
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR
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