Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04044937
Other study ID # 171022
Secondary ID NCI-2018-01875
Status Completed
Phase Phase 2
First received
Last updated
Start date October 29, 2018
Est. completion date March 31, 2024

Study information

Verified date June 2024
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize the grade of glial neoplasms. Imaging agents such as FET can help oncologist to see the tumor better during a positron emission tomography (PET) scan.


Description:

PRIMARY OBJECTIVES: I. To determine if F-18 fluoroethyltyrosine (FET) PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas. II. To determine if FET PET can accurately differentiate between low-grade and high-grade gliomas in population 2. SECONDARY OBJECTIVES: I. 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. II. To determine if FET PET can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas. 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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Thomas Hope

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Misclassification rate for either having recurrent disease or not having recurrent disease for patients previously treated for glial and metastatic disease (Population 1) Radiologists will classify lesions as 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] Up to 6 months
Primary Misclassification rate for either high grade or low grade in patients with suspected neoplasms (Population 2) Readers will have access only to FET PET images for participants 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] Up to 6 months
Secondary Binary characterization of follow-up imaging as positive/negative for tumor recurrence Participants with available histology (performed within 4 weeks of FET scans) or follow-up imaging (performed within 6 months of FET scan) will be included and a composite truth standard for recurrence or treatment-related changes will be evaluated for each case. In the absence of pathology, the composite truth standard will use available clinical information to make a determination. Positive for tumor recurrence on follow-up imaging will be based on Response assessment in neuro-oncology criteria (RANO) criteria reads. Follow-up imaging has to be performed within six months of the FET PET imaging study to be considered for evaluation. Additionally, the composite truth standard may consider tumor board notes and subsequent management of the patient to make a determination. Up to 6 months
Secondary Misclassification rate for FET PET in the evaluation of recurrent low-grade gliomas (Population 1) 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] Up to 6 months
Secondary Degree of inter-rater reliability for tracer uptake Fleiss' kappa statistic will be used to determine the agreement between the assessment of FET-PET tumor targeting (tracer uptake in target lesion: yes/ no), as assessed by three independent blinded readers. Scores range from 0 to 1 with higher scores indicating a great degree of agreement Up to 6 months
Secondary Degree of inter-rater reliability for radiological interpretations Cohen's kappa statistics will be used to determine the reproducibility of the assessment by individual readers when analyzing the same data repeatedly and measures the agreement between two raters who each classify items into mutually exclusive categories. Up to 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05577091 - Tris-CAR-T Cell Therapy for Recurrent Glioblastoma Phase 1
Recruiting NCT05284643 - Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma N/A
Recruiting NCT05039281 - Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma Phase 1/Phase 2
Recruiting NCT04988750 - Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients N/A
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT00503204 - Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour Phase 1
Completed NCT03216499 - HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma Phase 2
Not yet recruiting NCT04717999 - Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma N/A
Not yet recruiting NCT05540275 - Tislelizumab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for Bevacizumab Refractory Recurrent Glioblastoma Phase 2
Recruiting NCT04528680 - Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma Phase 1/Phase 2
Recruiting NCT04888611 - Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma Phase 2
Completed NCT00390299 - Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme Phase 1
Recruiting NCT05463848 - Surgical Pembro +/- Olaparib w TMZ for rGBM Phase 2
Active, not recruiting NCT04479241 - LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma Phase 2
Active, not recruiting NCT00777153 - Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma Phase 3
Withdrawn NCT05017610 - Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma Early Phase 1
Recruiting NCT04323046 - Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults Phase 1
Active, not recruiting NCT05324501 - A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma Phase 1
Withdrawn NCT05666349 - Reirradiation and Niraparib in Patients With Recurrent Glioblastoma Phase 1
Active, not recruiting NCT04440358 - Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM Phase 1/Phase 2