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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00936 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA086862 | U.S. NIH Grant/Contract | View source | |
| R01CA167632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies gallium Ga 68-edotreotide positron emission tomography (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of patients with neuroendocrine tumors.
PRIMARY OBJECTIVES:
I. To compare efficacy of [68Ga]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution, contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor expressing tumors.
OUTLINE:
Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may also undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (gallium Ga 68-edotreotide PET/CT) | Experimental | Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gallium Ga 68-edotreotide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT. | Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first) |
| Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan | Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors | Up to 6 months |
| Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan | Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Sue O' Dorisio, MD, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 26, 2015 |
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| positron emission tomography/computed tomography | Procedure | Undergo gallium Ga 68-edotreotide PET/CT scan |
|
| indium In 111 pentetreotide | Radiation | Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan |
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| computed tomography | Procedure | Undergo indium In 111 pentetreotide contrast-enhanced CT scan |
|
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| contrast-enhanced magnetic resonance imaging | Procedure | Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan |
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| COMPLETED |
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| NOT COMPLETED |
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68 patients enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | eligible participants |
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| 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 | Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology | Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT. | Patients with neuroendocrine tumor or other somatostatin receptor positive tumor | Posted | Count of Participants | Participants | Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first) |
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| ||||||||||||||||||||||||||||||
| Primary | Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan | Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors | Patients with neuroendocrine tumor or other somatostatin receptor positive tumor | Posted | Number | percentage of sensitivity | Up to 6 months |
|
| |||||||||||||||||||||||||||||||
| Primary | Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan | Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors | Patients with neuroendocrine tumor or other somatostatin receptor positive tumor | Posted | Number | percentage of specificity | 6 months |
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Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
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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 | Diagnostic (Gallium Ga 68-edotreotide PET/CT) | Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed. gallium Ga 68-edotreotide: Given IV positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan | 1 | 68 | 0 | 68 | 11 | 68 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment | cramping |
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| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | CTCAE v4.0 | Systematic Assessment | chills |
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| Pain | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment | joint stiffness |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Flushing | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
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| Vascular disorders - Other, specify | Vascular disorders | CTCAE v4.0 | Systematic Assessment | skin mottling |
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Although 67/68 were eligible and received the 68Ga-DOTATOC PET scan, four patients did not receive the 111In-Octreotide SPECT scan. Of the 63 subjects who received both scans, 30 subjects did not receive the 111In-Octreotide SPECT scan within either the six months prior to or six months after the 68Ga-DOTATOC PET scan. This left only 34 subjects who could be fully evaluated for comparison of number of lesions found on both scans.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Sue O'Dorisio, MD, PhD | University of Iowa | 319-335-7234 | sue-odorisio@uiowa.edu |
| Feb 14, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2015 | Feb 14, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008527 | Medulloblastoma |
| D009447 | Neuroblastoma |
| D018358 | Neuroendocrine Tumors |
| D013005 | Somatostatinoma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018278 | Carcinoma, Neuroendocrine |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D018273 | Carcinoma, Islet Cell |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C513399 | gallium Ga 68 dotatate |
| D009682 | Magnetic Resonance Spectroscopy |
| C081788 | pentetreotide |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Total negative |
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| Sensitivity and Specificity for OctreoScan as Compared to Pathology |
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