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

NCT ID: NCT03990285

Last Updated: 2021-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2021-11-18

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.

Detailed Description

This is a pilot study in subjects with a histologically proven diagnosis of glioblastoma (GB) who have completed chemoradiation and now have new contrast enhancing lesions or lesions showing increased enhancement ( 25% increase) who are recommended for a clinical surgical resection. Subjects may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Subjects who come to the University of Pennsylvania for diagnosis and/or treatment of GB and who meet the study inclusion criteria may be approached by study personnel for recruitment into this study. Subjects will be approached about study participation regardless of race or ethnic background. Investigators anticipate enrolling up to 30 participants. Subjects who consent but do not complete the study imaging will be considered not evaluable and will be replaced. Accrual will likely occur over approximately 1-2 years. After undergoing screening assessments and verifying eligibility for study participation subjects will undergo a research 18FFluciclovine PET/CT scan of the brain and a clinical brain MRI with and without gadolinium contrast, all baseline imaging will be done prior to (within 1 week) of the surgical procedure. The PET-CT and MRI can be performed in any order.

Conditions

Glioma Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[18F]Fluciclovine in glioblastoma

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.

Group Type: OTHER

Axumin, Intravenous Solution

Intervention Type: DRUG

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

Interventions

Axumin, Intravenous Solution

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants will be ≥ 18 years of age

2. Initial diagnosis of glioblastoma (histologic or molecular proof)

3. Completion of chemoradiation

4. New contrast-enhancing lesion or lesions showing increased enhancement (>25% increase) on standard MRI after completion of chemoradiation

5. Recommended for clinically surgical resection

6. Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.

7. Karnofsky performance status ≥ 60

8. 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

Exclusion Criteria

1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

2. 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.

3. 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

4. Contraindications to MRI or use of gadolinium contrast

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blue Earth Diagnostics

INDUSTRY

Sponsor Role: collaborator

Ali Nabavizadeh

OTHER

Sponsor Role: lead

Responsible Party

Ali Nabavizadeh

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34081125 (View on PubMed)

Other Identifiers

UPCC 08319/ IRB# 832812

Identifier Type: -

Identifier Source: org_study_id