This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.
PRIMARY OBJECTIVES: I. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging. SECONDARY OBJECTIVES: I. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient. OUTLINE: Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes. After completion of study, patients are followed up for 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
Undergo Gallium Ga 68-DOTA-TOC PET/CT
Given Intravenously (IV) before imaging
Undergo gallium Ga 68-DOTA-TOC PET/MRI
Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI
University of California, San Francisco
San Francisco, California, United States
Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT
Time frame: 1 day
Standardized Uptake Value Maximum (SUVmax)
The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.
Time frame: 1 day
Inter-reader Variability
Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.
Time frame: 1 day
Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging
Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both "Change in stage" with a 95% confidence interval determined.
Time frame: Up to 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.