Condition or disease | Intervention/treatment | Phase |
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Glioblastoma | Procedure: Computed Tomography Other: Fluciclovine F18 Procedure: Positron Emission Tomography | Early Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
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 30, 2019 |
Estimated Primary Completion Date : | February 15, 2020 |
Estimated Study Completion Date : | February 15, 2020 |
Arm | Intervention/treatment |
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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.
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Procedure: Computed Tomography
Undergo PET/CT scan
Other Names:
Other: Fluciclovine F18 Given IV
Other Names:
Procedure: Positron Emission Tomography Undergo PET/CT scan
Other Names:
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:
Contact: Jason M Johnson | 713-792-8443 | jjohnson12@mdanderson.org |
United States, Texas | |
M D Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Jason M. Johnson 713-792-8443 | |
Principal Investigator: Jason M. Johnson |
Principal Investigator: | Jason M Johnson | M.D. Anderson Cancer Center |
Tracking Information | |||||
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First Submitted Date ICMJE | April 23, 2019 | ||||
First Posted Date ICMJE | April 24, 2019 | ||||
Last Update Posted Date | November 27, 2019 | ||||
Actual Study Start Date ICMJE | April 30, 2019 | ||||
Estimated Primary Completion Date | February 15, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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.
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery | ||||
Official Title ICMJE | Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Early Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Glioblastoma | ||||
Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
25 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | February 15, 2020 | ||||
Estimated Primary Completion Date | February 15, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03926507 | ||||
Other Study ID Numbers ICMJE | 2018-0869 NCI-2019-01532 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0869 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | November 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |