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NCT05054400 Clinical Trial

Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR

Cancer Clinical Trial

Official title:
Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05054400
Other study ID # 2019-1030
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date February 5, 2020
Est. completion date August 29, 2023

Study information
Verified date August 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 29, 2023
Est. primary completion date August 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• F18 Fluciclovine
Given by IV
Other:
• Standard of Care
Standard of care

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To establish the relationship between brain malignancy volume as defined by post-contrast T1 weighted and F18 Fluciclovine before and following LITT. through study completion, an average of 1 year
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