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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• Phase: Early Phase 1
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Cancer
• Glioblastoma
• Gliomas

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

External Links

•   M D Anderson Cancer Center