F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery

Glioblastoma Clinical Trial

Official title:

Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926507
• Other study ID #: 2018-0869
• Secondary ID: NCI-2019-0153220
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: September 18, 2023

Study information

• Verified date: September 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This early phase I trial studies how well F18 fluciclovine positron emission tomography (PET)/computed tomography (CT) works in assessing tumor volume and radiation therapy response in patients with glioblastoma undergoing surgery. Radioactive imaging agents, such as F18 fluciclovine, used during PET/CT scan may help measure tumor size compared to standard of care magnetic resonance imaging (MRI) contrast agents in patients receiving radiation therapy.

Description:

PRIMARY OBJECTIVES:

I. To compare fluciclovine F18 (F18 fluciclovine) PET CT for tumor volume assessment compared to T2 fluid attenuated inversion recovery (FLAIR) and T1 post contrast magnetic resonance (MR) brain imaging.

SECONDARY OBJECTIVES:

I. To assess changes in F18 fluciclovine defined disease with surgery and radiation.

II. To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity.

EXPLORATORY OBJECTIVES:

I. To assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging.

OUTLINE:

Patients receive fluciclovine F18 intravenously (IV) and undergo 4 PET/CT scans over 10 minutes paired with standard of care MRI within 14 days prior to initial maximal tumor resection, within 7 days prior to initiation of radiation therapy, 28 days after the completion of radiation therapy, and 6 months after the completion of radiation therapy.

After completion of study, patients will be followed up at 3 and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is a candidate for brain tumor resection and radiation with lesion suspected to be or previously biopsy proven to be a glioblastoma.

• Patient is able to understand and give consent to participation in the study.

Exclusion Criteria:

• Pregnant.

• Known allergy to gadolinium-based contrast agents or F18 fluciclovine.

• Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m^2.

• Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:

• Electronically, magnetically, and mechanically activated implants

• Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers

• Metallic splinters in the eye

• Ferromagnetic hemostatic clips in the central nervous system (CNS) or body

• Cochlear implants

• Other pacemakers, e.g., for the carotid sinus

• Insulin pumps and nerve stimulators

• Non-MR safe lead wires

• Prosthetic heart valves (if dehiscence is suspected)

• Non-ferromagnetic stapedial implants

• Pregnancy

• Claustrophobia that does not readily respond to oral medication.

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT scan

Other:
• Fluciclovine F18
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT scan

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Results from pathology	Will use rank correlation analysis to assess the association between results from pathology and F18 fluciclovine, T2 FLAIR, and T1 post-contrast MR brain imaging. The association between tumor histology (glioma/non-glioma) and grade and tumor volumes from imaging results will be assessed using Wilcoxon rank-sum tests and rank correlation.	Up to 6 months
Primary	Tumor volume	Will be assessed with fluciclovine F18 (F18 fluciclovine) positron emission tomography (PET) computed tomography (CT). The three volumes measured (amino acid hypermetabolic volume [AHV], T2 fluid attenuated inversion recovery [FLAIR] and T1 contrast [T1C]) will be compared to each other for each patient, and plotted as boxplots, both raw (as mL) and as normalized values (to the T1C volume) to facilitate comparisons between patients.	Up to 6 months
Secondary	Changes in F18 fluciclovine defined disease with surgery and radiation	Will compare tumor volumes measured by this method between the initial time point and the three follow-up time points within patients using Wilcoxon rank-sum tests.	Baseline up to 6 months
Secondary	Post-radiation enhancing brain tissue	To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity, will use rank correlation analysis.	Up to 6 months

External Links

•   MD Anderson Cancer Center