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Trial record 5 of 23 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | Glioma | United States | Start date from 04/01/2019 to 07/31/2019

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

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ClinicalTrials.gov Identifier: NCT03990285
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Blue Earth Diagnostics
Information provided by (Responsible Party):
Seyed Ali Nabavizadeh, MD, University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
Glioma Glioblastoma Multiforme Drug: Axumin, Intravenous Solution Phase 1

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.

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Study Type : Interventional
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multimodality 18F-Fluciclovine PET, MRI and Cell Free Circulating DNA to Differentiate Tumor Progression From Pseudoprogression in Patients With Glioblastoma
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
[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.
Drug: Axumin, Intravenous Solution
To compare 18F-fluciclovine PET uptake measures in glioblastoma patients with tumor progression versus pseudoprogression




Primary Outcome Measures :
  1. Pseudoprogression or tumor progression by histopathology [ Time Frame: 2Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990285


Contacts
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Contact: Leeanne Lezotte 215-615-5462 leeanne.lezotte@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Leeanne Lezotte    215-615-5462      
Contact: Lisa Desiderio    215-746-7632      
Principal Investigator: Seyed Ali Nabavizadeh, MD         
Sponsors and Collaborators
Seyed Ali Nabavizadeh, MD
Blue Earth Diagnostics

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Responsible Party: Seyed Ali Nabavizadeh, MD, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03990285     History of Changes
Other Study ID Numbers: IRB 832812/UPCC 08319
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue