Fluoroethyltyrosine in Detecting Tumors in Participants With Recurrent Intracranial Tumors
Study Details
Study Description
Brief Summary
This phase II trial studies how well F-18 fluoroethyltyrosine (fluoroethyltyrosine) works in detecting tumors in participants with intracranial tumors that have come back. Imaging agents, such as fluoroethyltyrosine, may help doctors see the tumor better during a positron emission tomography (PET) scan.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
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To determine if F-18 fluoroethyltyrosine (FET) PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology alone in population 1.
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To determine if FET PET can accurately differentiate between low-grade and high-grade glial neoplasms in population 2.
SECONDARY OBJECTIVES:
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To determine if FET PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology or imaging follow-up in population 1.
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To determine if FET PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology alone in population 1 patients with recurrent low-grade gliomas (grades 1 and 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Diagnostic FET PET All participants 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. |
Drug: F-18 Fluoroethyltyrosine (FET)
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:
Procedure: Positron Emission Tomography (PET)
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:
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Outcome Measures
Primary Outcome Measures
- Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 1) [Day 1]
Radiologists will classify lesions based on imaging as either having recurrent disease or not having recurrent disease. True Positives (TP) are defined as an FET PET read positive for tumor and pathology/follow-up demonstrates tumor recurrence in at least one biopsy sample, False positives (FP) are defined as an FET PET read positive for tumor and pathology/follow-up demonstrates negative tumor recurrence in all of the biopsy samples, True negatives (TN) are defined as an FET PET read as negative for tumor and pathology/follow-up also negative tumor recurrence in all of the biopsy samples and a false negative (FN) is defined as an FET PET read as negative for tumor and pathology/follow-up demonstrates tumor recurrence in at least one biopsy sample. Misclassification rate = [FP+FN)]/[FP+FN+TP+TN]
- Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2) [Day 1]
Readers will have access only to FET PET images for Patients with suspected glial neoplasms (Grade 2-4) planning to undergo biopsy or surgery prior to primary treatment during evaluation and will grade the lesions in a binary fashion as having Grade II glial neoplasms or having Grade III/IV glial neoplasms. True positive (TP2): FET PET read as positive for Grade III/IV neoplasm, pathology demonstrates Grade III/IV neoplasm. False positive (FP2): FET PET read as positive for Grade III/IV neoplasm, pathology demonstrates Grade II neoplasm. True negative (TN2): FET PET read as positive for Grade II neoplasm, pathology demonstrates Grade II neoplasm. False negative (FN2): FET PET read as positive for Grade II neoplasm, pathology demonstrates Grade III/IV neoplasm. Misclassification rate = [FP2+FN2]/[FP2+FN2+TP2+TN2]
Secondary Outcome Measures
- Binary characterization of follow-up imaging as positive/negative for tumor recurrence [Up to 6 months]
In the absence of pathology, imaging will be used for correlation. Positive for tumor recurrence on follow-up imaging as correlate endpoint will be defined as a greater than 50% increase in the enhancing component of the lesion. If there is less than 50% increase in the enhancing component of the lesion, then it will be considered negative for tumor recurrence on follow-up. Follow-up imaging has to be performed within six months of the FET PET imaging study.
- Misclassification rate for FET PET in the evaluation of recurrent low-grade gliomas (Population 1) [Up to 6 months]
Low-grade glioma is defined by low uptake of FET. Radiologists will classify lesions based on imaging as either having recurrent disease or not having recurrent disease. True Positives (TP1L) are defined as an FET PET read positive for low-grade tumor and pathology/follow-up demonstrates low-grade tumor recurrence in at least one biopsy sample, False positives (FP1L) are defined as an FET PET read positive for low grade tumor recurrence and pathology/follow-up demonstrates negative low-grade tumor recurrence in all of the biopsy samples, True negatives (TN1L) are defined as an FET PET read as negative for low-grade tumor recurrence and pathology/follow-up also negative for low grade tumor recurrence in all of the biopsy samples and a false negative (FN1L) is defined as an FET PET read as negative for low grade tumor recurrence and pathology/follow-up demonstrates low grade tumor recurrence in at least one biopsy sample. Misclassification rate = [FP1L+FN1L)]/[FP1L+FN1L+TP1L+TN1L]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 3 years.
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Presence or suspicion of intracranial neoplasm in two populations.
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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:
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Recurrent metastatic lesions.
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Recurrent high-grade gliomas (grades 3 and 4).
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Recurrent low-grade gliomas (grades 1 and 2).
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Population 2: Patients prior to primary treatment with planned biopsy or surgical resection.
Exclusion Criteria:
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Patient with known incompatibility to PET or computed tomography (CT)/MRI scans.
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Patient unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation.
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Sedation or anesthesia can be used for patients who cannot tolerate the exam.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94115 |
Sponsors and Collaborators
- Thomas Hope
Investigators
- Principal Investigator: Thomas A Hope, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 171022
- NCI-2018-01875