GA-68 DOTA-TOC of Somatostatin Positive Malignancies (DOTA-TOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02177773|
Recruitment Status : Terminated (FDA approved agent for this indication during enrollment)
First Posted : June 30, 2014
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumor Paraganglioma Carcinoid Tumors Neuroblastoma||Procedure: Computed Tomography (CT) Drug: Gallium Ga 68-Edotreotide Procedure: Magnetic Resonance Imaging (MRI) Procedure: Positron Emission Tomography (PET)||Phase 1 Phase 2|
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.
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.
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 (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Gallium-68 DOTA-TOC Imaging of Somatostatin Receptor Positive Malignancies|
|Actual Study Start Date :||June 23, 2014|
|Actual Primary Completion Date :||August 7, 2017|
|Actual Study Completion Date :||August 7, 2017|
Experimental: Ga-68 DOTA-TOC PET/CT
Patients receive Gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo either a PET/CT scan lasting 30-40 minutes or a PET/MRI scan lasting 50 minutes.
Procedure: Computed Tomography (CT)
Undergo Gallium Ga 68-DOTA-TOC PET/CT
Drug: Gallium Ga 68-Edotreotide
Given Intravenously (IV) before imaging
Procedure: Magnetic Resonance Imaging (MRI)
Undergo gallium Ga 68-DOTA-TOC PET/MRI
Procedure: Positron Emission Tomography (PET)
Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI
- Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging [ Time Frame: 1 day ]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
- Standardized Uptake Value Maximum (SUVmax) [ Time Frame: 1 day ]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.
- Inter-reader Variability [ Time Frame: 1 day ]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.
- Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging [ Time Frame: Up to 2 weeks ]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.
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): NCT02177773
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Thomas A Hope, MD||University of California, San Francisco|