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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

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

Clinicaltrials.gov identifier NCT03926507

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted November 27, 2019

Study Description

Brief 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.

  • Condition or Disease:Glioblastoma
  • Intervention/Treatment: Procedure: Computed Tomography
    Other: Fluciclovine F18
    Procedure: Positron Emission Tomography
  • Phase: Early Phase 1
Detailed 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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 25 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: February 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Diagnostic (fluciclovine F18 PET/CT)
Patients receive fluciclovine F18 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.
Procedure: Computed Tomography
Undergo PET/CT scan

Other: Fluciclovine F18
Given IV

Procedure: Positron Emission Tomography
Undergo PET/CT scan
Outcome Measures
  • Primary Outcome Measures: 1. Tumor volume [ Time Frame: Up to 6 months ]
    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.
  • Secondary Outcome Measures: 1. Changes in F18 fluciclovine defined disease with surgery and radiation [ Time Frame: Baseline up to 6 months ]
    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.
  • 2. Post-radiation enhancing brain tissue [ Time Frame: Up to 6 months ]
    To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity, will use rank correlation analysis.
  • Other Outcome Measures: 1. Results from pathology [ Time Frame: Up to 6 months ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Jason M Johnson 713-792-8443 jjohnson12@mdanderson.org

Locations

United States, Texas
M D Anderson Cancer Center
Houston

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

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

More Information
  • Responsible Party: M.D. Anderson Cancer Center
  • ClinicalTrials.gov Identifier: NCT03926507 History of Changes
  • Other Study ID Numbers: 2018-0869, NCI-2019-01532, 2018-0869, P30CA016672
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: November 27, 2019
  • Last Verified: November 2019
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Glioblastoma