- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04044937
Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms (UC-GlioFET)
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if FET PET can differentiate between benign treatment-related changes (TRC) and recurrent glioma in comparison to a composite standard of truth (CSOT) that includes pathology and other clinical information, evaluated using estimates of sensitivity and specificity (Combined populations)
SECONDARY OBJECTIVES:
I. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a histopathological standard of truth.(Combined populations).
II. To determine if FET PET can differentiate between benign TRC and recurrent glioma in comparison to a CSOT evaluated using estimates other than subject-based sensitivity and specificity.(Combined populations).
III. To assess the safety of FET PET, as determined by treatment emergent adverse events (TEAEs) within 48 hours of FET administration.(Combined populations).
IV. To describe the inter-reader variability between 3 independent blinded readers of FET PET images in assessments of benign TRC versus recurrent glioma.(Combined populations).
V. To describe intra-reader variability between 3 independent blinded readers of FET PET images in the assessments of benign TRC versus recurrent glioma.(Combined populations).
EXPLORATORY OBJECTIVES:
I. To assess relationships between serial FET PET and clinical outcome (benign TRC and recurrence) in patients with recurrent metastatic lesions, recurrent high grade gliomas and recurrent low-grade gliomas.
II. To determine if MRI can differentiate between benign treatment-related changes and recurrence.
III. To describe the distribution of the standardized uptake value (SUV) and tumor-to-background ratio (TBR) for observed lesions.
IV. To determine if FET PET can differentiate between benign TRC and recurrent metastatic lesions.
V. To determine if FET PET can accurately differentiate between low-grade and high-grade gliomas (Population 2).
OUTLINE:
Participants receive F-18 fluoroethyltyrosine intravenously (IV) over approximately 1 minute and undergo PET over 40 minutes. After completion of study treatment, participants are followed up periodically.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 3 years.
Presence or suspicion of intracranial neoplasm in two populations.
Population 1: Patients after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on magnetic resonance imaging (MRI). Three sub-populations will be considered:
- Recurrent metastatic lesions.
- Recurrent high-grade gliomas (grades 3 and 4).
- Recurrent low-grade gliomas (grades 1 and 2).
- Population 2: Patients prior to primary treatment with planned biopsy or surgical resection.
Exclusion Criteria:
- Patient with known incompatibility to PET or computed tomography (CT)/MRI scans.
Patient unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
- Sedation or anesthesia can be used for patients who cannot tolerate the exam.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Population 1: Intracranial neoplasms (glial or metastatic disease)
Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging (e.g., MRI) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes.
Repeat FET PET will be offered to adult patients.
|
Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan.
The radiopharmaceutical will be administered while the patient is in the PET scanner
Other Names:
All patients receive single PET imaging lasting for 40 minutes.
Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection.
A repeat PET image will be offered to adult patients.
Other Names:
|
|
Experimental: Population 2: Suspected glial neoplasms
Participants with suspected glial neoplasms (Grade 2-4) planning to undergo a non-investigational biopsy or surgery prior to non-investigational, primary treatment (radiation therapy and/or surgery) will receive F-18 fluoroethyltyrosine (FET) injected intravenously over approximately 1 minute and receive a single PET image lasting up to 40 minutes.
Repeat FET PET will be offered to adult patients.
|
Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan.
The radiopharmaceutical will be administered while the patient is in the PET scanner
Other Names:
All patients receive single PET imaging lasting for 40 minutes.
Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection.
A repeat PET image will be offered to adult patients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of Fluoroethyltyrosine (FET) PET using a composite standard of truth (CSOT) (subject-level)
Time Frame: Up to 6 months
|
Sensitivity is defined as a percentage of all participants with a true positive (TP) FET PET scan result relative to participants with a positive CSOT result = [TP / (TP + FN)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
|
Up to 6 months
|
|
Specificity of FET PET using a CSOT (subject-level)
Time Frame: Up to 6 months
|
Specificity is defined as percentage of all participants with a true negative (TN) FET PET scan result relative to participants with a negative CSOT result = [TN / (TN + FP)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of FET PET using a histopathology standard of truth (subject-level)
Time Frame: Up to 6 months
|
Sensitivity is defined as percentage of all participants with a true positive (TP) FET PET scan result relative to all participants with a positive histological result = [TP / (TP + FN)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
|
Up to 6 months
|
|
Sensitivity of FET PET using a histopathology standard of truth (lesion-level)
Time Frame: Up to 6 months
|
Sensitivity is defined as percentage of all lesions with a true positive (TP) FET PET scan result relative to all lesions with a positive histological result = [TP / (TP + FN)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
|
Up to 6 months
|
|
Specificity of FET PET using a histopathology standard of truth (subject-level)
Time Frame: Up to 6 months
|
Specificity is defined as percentage of all participants with a true negative (TN) FET PET scan result relative to all participants with a negative histological result = [TN / (TN + FP)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
|
Up to 6 months
|
|
Specificity of FET PET using a histopathology standard of truth (lesion-level)
Time Frame: Up to 6 months
|
Specificity is defined as percentage of all lesions with a true negative (TN) scan result relative to all lesions with a negative histological result = [TN / (TN + FP)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
|
Up to 6 months
|
|
Positive Predictive Value (PPV) using a histopathology standard of truth (subject-level)
Time Frame: Up to 6 months
|
The positive predictive value for all participants is defined as the probability that a positive histological standard of truth result is obtained given that the result of the FET PET scan is positive and reported as a percentage across all participants = [TP / (TP + FP)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
|
Up to 6 months
|
|
Positive Predictive Value (PPV) using a histopathology standard of truth (lesion-level)
Time Frame: Up to 6 months
|
The positive predictive value for all lesions is defined as the probability that a positive histological standard of truth result is obtained given that the result of the FET PET scan is positive and reported as a percentage of all lesions = [TP / (TP + FP)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
|
Up to 6 months
|
|
Negative Predictive Value (NPV) using a histopathology standard of truth (subject-level)
Time Frame: Up to 6 months
|
The negative predictive value for all participants is defined as the probability that a negative standard of truth result is obtained given that the result of the FET PET scan is negative and reported as a percentage of all participants = [TN / (TN + FN)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
|
Up to 6 months
|
|
Negative Predictive Value (NPV) using a histopathology standard of truth (lesion-level)
Time Frame: Up to 6 months
|
The negative predictive value for all lesions is defined as the probability that a negative standard of truth result is obtained given that the result of the FET PET scan is negative and reported as a percentage of all lesions = [TN / (TN + FN)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
|
Up to 6 months
|
|
Accuracy of FET PET using a histopathology standard of truth (subject-level)
Time Frame: Up to 6 months
|
The accuracy is defined as the probability that the FET PET scan result for all participants is correct using histopathological results and reported as a percentage: Accuracy (%) = [(TP + TN) / (TP + FP + TN + FN)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
|
Up to 6 months
|
|
Accuracy of FET PET using a histopathology standard of truth (lesion-level)
Time Frame: Up to 6 months
|
The accuracy is defined as the probability that the FET PET scan result for all lesions is correct using histopathological results and reported as a percentage: Accuracy (%) = [(TP + TN) / (TP + FP + TN + FN)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
|
Up to 6 months
|
|
Misclassification rate for FET PET using a histopathology standard of truth (Subject-level)
Time Frame: Up to 6 months
|
The misclassification rate is defined as the probability that the FET PET scan result for all participants is not correct using histopathological results and reported as a percentage: Misclassification Rate (%) = [(FP + FN) / (TP + FP + TN + FN)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each subject.
|
Up to 6 months
|
|
Misclassification rate for FET PET using a histopathology standard of truth (lesion-level)
Time Frame: Up to 6 months
|
The misclassification rate is defined as the probability that the FET PET scan result for all lesions is not correct using histopathological results and reported as a percentage: Misclassification Rate (%) = [(FP + FN) / (TP + FP + TN + FN)] x 100.
For cases with available histopathology, the histopathology standard of truth for recurrence (positive) or TRC (negative) will also be determined by the Truth Panel as an intermediate result while reviewing histopathology as part of their overall assessment of each lesion.
|
Up to 6 months
|
|
Sensitivity of FET PET using a CSOT (lesion-level)
Time Frame: Up to 6 months
|
Sensitivity is defined as a percentage of all lesions with a true positive (TP) FET PET scan result relative to lesions with a positive CSOT result = [TP / (TP + FN)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion.
|
Up to 6 months
|
|
Specificity of FET PET using a CSOT (lesion-level)
Time Frame: Up to 6 months
|
Specificity is defined as percentage of all lesions with a true negative (TN) FET PET scan result relative to lesions with a negative CSOT result = [TN / (TN + FP)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion.
|
Up to 6 months
|
|
PPV of FET PET using a CSOT (subject-level)
Time Frame: Up to 6 months
|
The positive predictive value is defined as the probability that a positive CSOT result is obtained given that the result of the FET PET scan is positive, PPV (%) = [TP / (TP + FP)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
|
Up to 6 months
|
|
PPV of FET PET using a CSOT (lesion-level)
Time Frame: Up to 6 months
|
The positive predictive value is defined as the probability that a CSOT result is obtained given that the result of the FET PET scan is positive PPV (%) = [TP / (TP + FP)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion.
|
Up to 6 months
|
|
NPV of FET PET using a CSOT (subject-level)
Time Frame: Up to 6 months
|
The negative predictive value is defined as the probability that a negative CSOT result is obtained given that the result of the FET PET scan is negative, NPV (%) = [TN / (TN + FN)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
|
Up to 6 months
|
|
NPV of FET PET using a CSOT (lesion-level)
Time Frame: Up to 6 months
|
The negative predictive value is defined as the probability that a negative CSOT result is obtained given that the result of the FET PET scan is negative, NPV (%) = [TN / (TN + FN)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion.
|
Up to 6 months
|
|
Accuracy of FET PET using a CSOT (subject-level)
Time Frame: Up to 6 months
|
The accuracy is defined as the probability that the FET PET scan result is correct, Accuracy (%) = [(TP + TN) / (TP + FP + TN + FN)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
|
Up to 6 months
|
|
Accuracy of FET PET using a CSOT (lesion-level)
Time Frame: Up to 6 months
|
The accuracy is defined as the probability that the FET PET scan result is correct, Accuracy (%) = [(TP + TN) / (TP + FP + TN + FN)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion.
|
Up to 6 months
|
|
Misclassification rate for FET PET using CSOT (subject-level)
Time Frame: Up to 6 months
|
The misclassification rate is defined as the probability that the FET PET scan result is not correct, Misclassification Rate (%) = [(FP + FN) / (TP + FP + TN + FN)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion, and this will be considered together with the patient-level determination.
|
Up to 6 months
|
|
Misclassification rate for FET PET using CSOT (lesion-level)
Time Frame: Up to 6 months
|
The misclassification rate is defined as the probability that the FET PET scan result is not correct, Misclassification Rate (%) = [(FP + FN) / (TP + FP + TN + FN)] x 100.
The CSOT for recurrence or benign treatment-related changes (TRC) will be evaluated by a panel of physicians independent of FET images and determined based on histopathology and other clinical data.
Histopathology of target lesions obtained may be reviewed for up to 6 months after imaging.
Positive for recurrence on follow-up scans will be based on Response Assessment in Neuro-Oncology (RANO) 2.0 criteria.
For lesion-level standards, features of RANO will be considered.
Histopathology and imaging will be primary factors used in determinations, followed by additional clinical data.
From this, an overall determination will be made for each individual lesion.
|
Up to 6 months
|
|
Degree of inter-rater reliability
Time Frame: Up to 6 months
|
Inter-reader variability will be analyzed using Fleiss' kappa statistic to determine the agreement between three independent blinded readers in assessing FET PET images as recurrence or TRC.
Fleiss's kappa ranges from 0 to 1, where 0 indicates no agreement beyond chance, 1 indicates perfect agreement among all raters.
|
Up to 6 months
|
|
Reproducibility of inter-rater reliability
Time Frame: Up to 6 months
|
Intra-reader variability will be analyzed based on a random sample of 15 subjects whose images were re- reviewed by the same reader.
The percent of agreement between the two interpretations will be computed for each reader.
Cohen's kappa statistics will be used to determine the reproducibility of the assessment by individual readers when analyzing the same data repeatedly.
Cohen's Kappa ranges from -1 to 1, where-1 indicates complete disagreement between raters, 0 indicates agreement no better than chance, 1 indicates complete agreement between raters.
|
Up to 6 months
|
|
Proportion of all participants with reported treatment-emergent adverse events (TEAEs)
Time Frame: Up to 48 hours after FET PET imaging
|
The proportion of all participants who have reported grade 3 and above adverse events after receiving interventional scan will be recorded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4 will be reported.
|
Up to 48 hours after FET PET imaging
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas A Hope, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioblastoma
- Brain Neoplasms
- Investigative Techniques
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Magnetic Resonance Spectroscopy
- (18F)fluoroethyltyrosine
Other Study ID Numbers
- 171022
- NCI-2018-01875 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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