[18F]Fluciclovine in Post-treatment Glioblastoma ( Axumin )

NCT03990285 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: UPCC 08319/ IRB# 832812
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects with histologically proven glioblastoma (GBM) who are suspected to have progression and are candidates for a surgical resection according to standard of care may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age. Positron emission tomography (PET/CT) imaging will be used to evaluate fluciclovine uptake at sites of suspected progression before planned surgery. In addition, clinical brain MRI with and without contrast will be used to evaluate the tumor pre-operatively. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions. Investigators anticipate enrolling up to 30 subjects who will undergo a clinical brain MRI examination with and without contrast and a research 18F-Fluciclovine PET/CT scan of the brain prior to surgery. They will also have a blood draw preoperatively to collect samples for cfDNA analysis. PET/CT imaging sessions will include an injection of approximately 5 mCi (range for most studies is anticipated to be 5 mCi +/- 20%) of 18F-Fluciclovine.

Conditions

Glioma Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Pseudoprogression or tumor progression by histopathology

  2Years

Study Arms (1)

[18F]Fluciclovine in glioblastoma

OTHER

Axumin is a positron emitting radiopharmaceutical that has been studied in vivo in humans in a number of tumor types with positron emission tomography (PET/CT). 18F-Fluciclovine is a fluorine-18 labeled synthetic amino acid analog that is FDA approved as a PET imaging agent for prostate cancer recurrence, however, it has also been tested in other tumors. Investigators will use a typical dose of 18F-fluciclovine that is used for clinical studies in glioblastoma. This will be 5 mCi (approximate range for most studies is anticipated to be 5 mCi +/- 20%), but a lesser dose may be injected if, in the opinion of a Nuclear Medicine Authorized User, complete imaging data could be generated.

Drug: Axumin, Intravenous Solution

Interventions

Axumin, Intravenous Solution DRUG

To compare 18F-fluciclovine PET uptake measures in glioblastoma patients with tumor progression versus pseudoprogression

[18F]Fluciclovine in glioblastoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be ≥ 18 years of age
• Initial diagnosis of glioblastoma (histologic or molecular proof)
• Completion of chemoradiation
• New contrast-enhancing lesion or lesions showing increased enhancement (\>25% increase) on standard MRI after completion of chemoradiation
• Recommended for clinically surgical resection
• Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.
• Karnofsky performance status ≥ 60
• Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures

You may not qualify if:

• Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
• Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
• Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
• Contraindications to MRI or use of gadolinium contrast

Sponsors & Collaborators

• Ali Nabavizadeh: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 34081125 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

fluciclovine F-18

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: To compare 18F-fluciclovine PET uptake measures in glioblastoma patients with tumor progression vs pseudoprogression. To determine a multidimensional signature using 18F-fluciclovine PET, MRI, and plasma cfDNA that accurately differentiates tumor progression from pseudoprogression in post-chemoradiation GBM.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 18, 2019
• Study Start: June 12, 2019
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)