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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05054400
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jason Johnson
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Metastases, Cancer, Gliomas, Glioblastoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Other: F18 Fluciclovine

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

Interventions

Drug: - F18 Fluciclovine

Given by IV

Other: - Standard of Care

Standard of care

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Address

M D Anderson Cancer Center

Houston, Texas, 77031

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