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出境医 / 临床实验 / F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery
F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma | Procedure: Computed Tomography Other: Fluciclovine F18 Procedure: Positron Emission Tomography | Early Phase 1 |
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.
Study Design
| 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 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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.
|
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:
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Changes in F18 fluciclovine defined disease with surgery and radiation [ Time Frame: Baseline up to 6 months ]Will compare tumor volumes measured by this method between the initial time point and the three follow-up time points within patients using Wilcoxon rank-sum tests.
- Post-radiation enhancing brain tissue [ Time Frame: Up to 6 months ]To assess the relationship between post-radiation enhancing brain tissue and F18 fluciclovine activity, will use rank correlation analysis.
Other 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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.
Contacts and Locations
Contacts
| Contact: Jason M Johnson | 713-792-8443 | jjohnson12@mdanderson.org |
Locations
| 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 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Jason M Johnson | M.D. Anderson Cancer Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| 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 | ||||
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* 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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