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

NCT05054400 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 2019-1030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases; Cancer; Gliomas; Glioblastoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

F18 Fluciclovine

OTHER

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

Drug: F18 Fluciclovine; Other: Standard of Care

Interventions

F18 Fluciclovine DRUG

Given by IV

F18 Fluciclovine

Standard of Care OTHER

Standard of care

F18 Fluciclovine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77031, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Brain Neoplasms; Neoplasms; Glioma; Glioblastoma

Interventions

fluciclovine F-18; Standard of Care

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jason Johnson

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 23, 2021
• Study Start: February 5, 2020
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

US (1)