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

August 30, 2023 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77031
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: F18 Fluciclovine
radioactive imaging agent help researchers better "see" how the disease is responding to laser interstitial thermal therapy (LITT)
Drug: F18 Fluciclovine
Given by IV
Other: Standard of Care
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Jason Johnson, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Actual)

August 29, 2023

Study Completion (Actual)

August 29, 2023

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on F18 Fluciclovine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe