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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00451 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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FDA approved agent for this indication during enrollment
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| Name | Class |
|---|---|
| Peterson Family Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ga-68 DOTA-TOC PET/CT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography (CT) | Procedure | Undergo Gallium Ga 68-DOTA-TOC PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Hope, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DOTATOC Imaging | All patients received a single DOTATOC imaging study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes. Computed Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT Gallium Ga 68-Edotreotide: Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo gallium Ga 68-DOTA-TOC PET/MRI Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/CT Positron Emission Tomography: Undergo gallium Ga 68-DOTA-TOC PET/MRI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication. | Posted | 1 day |
Two weeks
All patients receiving Ga-68 DOTA-TOC were evaluated for safety. Safety parameters include physical findings and spontaneous reports of adverse events (AEs) reported to investigator by patients. Any grade 3 and above AEs were recorded. Patients were followed for two weeks after enrollment by phone, and all AEs were followed with appropriate medical management until resolved.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DOTATOC Imaging | All patients received a single DOTATOC imaging study. | 0 |
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Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Hope, MD | Unviersity of California, San Francisco | (415) 221-4810 | 22648 | thomas.hope@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2015 | Sep 9, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2017 | Oct 18, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D010235 | Paraganglioma |
| D002276 | Carcinoid Tumor |
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C513399 | gallium Ga 68 dotatate |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Gallium Ga 68-Edotreotide | Drug | Given Intravenously (IV) before imaging |
|
|
| Magnetic Resonance Imaging (MRI) | Procedure | Undergo gallium Ga 68-DOTA-TOC PET/MRI |
|
|
| Positron Emission Tomography (PET) | Procedure | Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI |
|
|
| Up to 2 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | DOTATOC Imaging | All patients received a single DOTATOC imaging study. |
|
| Primary | 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. | Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication. | Posted | 1 day |
|
|
| Secondary | 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. | Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication. | Posted | Up to 2 weeks |
|
|
| Primary | 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. | Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication. | Posted | 1 day |
|
|
| 300 |
| 0 |
| 300 |
| 0 |
| 300 |
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| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |