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

Early Phase 1

Withdrawn

• Conditions: Brain Metastases; Glioblastoma; Gliomas; Cancer
• Interventions: Drug: F18 Fluciclovine; Other: Standard of Care

• Registration Number: NCT05054400
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-05
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-23
• Status Verified: 2023-08
• Primary Completion: 2023-08-29
• Study Completion: 2023-08-29
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F18 Fluciclovine	F18 Fluciclovine	radioactive imaging agent help researchers better "see" how the disease is responding to laser interstitial thermal therapy (LITT)
F18 Fluciclovine	Standard of Care	radioactive imaging agent help researchers better "see" how the disease is responding to laser interstitial thermal therapy (LITT)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States