18F-FSPG PET/CT for Cancer Patients on Therapy
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|ClinicalTrials.gov Identifier: NCT02599194|
Recruitment Status : Completed
First Posted : November 6, 2015
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Neoplasm Estrogen Receptor Negative HER2/Neu Negative Metastatic Renal Cell Cancer Progesterone Receptor Negative Stage III Mesothelioma Stage III Renal Cell Cancer Stage IIIA Breast Cancer Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Stage IV Mesothelioma Stage IV Non-Small Cell Lung Cancer Stage IV Renal Cell Cancer Triple-Negative Breast Carcinoma||Drug: 18F-FSPG Drug: 18F-FDG||Phase 2|
Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.
Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.
- Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.
- Safety and tolerability of 18F-FSPG and 18F-FDG.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Intra-patient comparison of 2 different radiolabels|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 14, 2016|
|Actual Study Completion Date :||December 14, 2016|
Experimental: 18F-FSPG and 18F-FDG Intragroup Comparision
Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
Administered intravenously (IV)
Administered intravenously (IV)
Other Name: [18F]-Fluorodeoxyglucose ([18F]-FDG)
- Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment [ Time Frame: Baseline and up to 2 years ]Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
- Number of Treatment-Related Adverse Events [ Time Frame: Baseline to up to 2 years ]Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.
- Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs [ Time Frame: Baseline and up to 2 years ]Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599194
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94304|
|Principal Investigator:||Andrei M Iagaru, MD||Stanford University|