Clinical trial NCT03926507: F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery
Official title: Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Tumor volume
timeFrame: Up to 6 months
Secondary outcomes:
measure: Changes in F18 fluciclovine defined disease with surgery and radiation
timeFrame: Baseline up to 6 months
measure: Post-radiation enhancing brain tissue
timeFrame: Up to 6 months
Other outcomes:
measure: Results from pathology
timeFrame: Up to 6 months
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jason M Johnson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.