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

NCT ID: NCT05054400

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2023-08-29

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.

Conditions

Brain Metastases; Cancer; Gliomas; Glioblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

F18 Fluciclovine

radioactive imaging agent help researchers better "see" how the disease is responding to laser interstitial thermal therapy (LITT)

Group Type: OTHER

F18 Fluciclovine

Intervention Type: DRUG

Given by IV

Standard of Care

Intervention Type: OTHER

Standard of care

Interventions

F18 Fluciclovine

Given by IV

Intervention Type: DRUG

Standard of Care

Standard of care

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Johnson

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

2019-1030

Identifier Type: -

Identifier Source: org_study_id