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This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer.
In total, 59 subjects will be recruited in the study. The study will recruit both healthy volunteers as well as patients with confirmed or suspicious NET disease by histology or conventional anatomical and functional imaging modalities including but not limited to magnetic resonance imaging (MRI), and/or computed tomography (CT), and/or, F-18 FDG fluorodeoxyglucose PET (positron emission tomography)/CT and /or F-18 NaF sodium fluoride bone PET/CT and/or bone scintigraphy, and/or Octreoscan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/CT imaging with 64Cu-DOTATATE | Experimental | 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on neuroendocrine cancer cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 64Cu-DOTATATE | Drug | Detection of somatostatin positive lesions in NET |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor | The number of patients with NETs disease that was confirmed by SSTR(+) imaging using 64Cu-DOTATATE PET/CT and In111-Octreoscan (considered as the standard of truth imaging) A total of 63 subjects have been enrolled in the studies; among them 42 patients with known or suspected NET based on histology, or conventional imaging, or clinical evaluations and 21 healthy volunteers. | 12 months |
| Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor | The number of subjects who have no SSTR (+) NETs as determined by 64Cu-DOTATATE PET/CT as well using the standard of truth imaging (In111-Octrescan SPECT/CT). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging | The number of patients with localized NETs or metastatic SSTR(+) neuroendocrine tumors that were detected by both 64Cu-DOTATATE and SOT | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebrahim S Delpassand, MD | Radiomedix, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excel Diagnostics and Nuclear Oncology Center | Houston | Texas | 77042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31924723 | Background | Delpassand ES, Ranganathan D, Wagh N, Shafie A, Gaber A, Abbasi A, Kjaer A, Tworowska I, Nunez R. 64Cu-DOTATATE PET/CT for Imaging Patients with Known or Suspected Somatostatin Receptor-Positive Neuroendocrine Tumors: Results of the First U.S. Prospective, Reader-Masked Clinical Trial. J Nucl Med. 2020 Jun;61(6):890-896. doi: 10.2967/jnumed.119.236091. Epub 2020 Jan 10. |
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Number of Subjects (planned and analyzed): 63 Analyzed: In total, 63 subjects (59 from the Phase 3 study and 4 from the Phase 1 study) were injected with study drug at an intended dose of 4.0 mCi and met the criteria to be analyzed for safety and efficacy.
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| ID | Title | Description |
|---|---|---|
| FG000 | PET/CT Imaging With 64Cu-DOTATATE | 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The following analysis populations were defined: Efficacy Evaluable (EE) Population - consisted of all subjects who were enrolled in the study had an established SOT, were injected with 64Cu DOTATATE, and had an image read result using 64Cu-DOTATATE by three independent readers.
Safety Population - The safety population consisted of all subjects who were enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | PET/CT Imaging With 64Cu-DOTATATE | 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor | The number of patients with NETs disease that was confirmed by SSTR(+) imaging using 64Cu-DOTATATE PET/CT and In111-Octreoscan (considered as the standard of truth imaging) A total of 63 subjects have been enrolled in the studies; among them 42 patients with known or suspected NET based on histology, or conventional imaging, or clinical evaluations and 21 healthy volunteers. | The number of patients with SSTR(+) NETs identified using 64Cu-DOTATATE PET-CT imaging as well as by the standard of truth methods. A total of 63 subjects have been enrolled in the studies, including 42 patients with known or suspected NET based on histology, conventional imaging, or clinical evaluations and 21 healthy volunteers. | Posted | Count of Participants | Participants | No | 12 months |
|
Any adverse events observed or reported were recorded for up to 48 hours following study drug administration. In addition, observed or patient reported immediate adverse events including but not limited to pain, injection site reaction, headache, nausea, vomiting, flushing or other as reported, were assessed within 1 hour before and within 2 hours after the study drug administration
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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 | PET/CT Imaging With 64Cu-DOTATATE | 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells. 64Cu-DOTATATE: Detection of somatostin positive lesions in NET |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea (grade 1) | Gastrointestinal disorders | MeDRA 10 | Systematic Assessment | All adverse events were either mild or moderate in severity. There were no adverse events that were severe, life-threatening or disabling, or that resulted in death. Adverse events that were mild in severity included nausea, vomiting, headache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ebrahim Delpassand | RadioMedix Inc | 7134999733 | edelpassand@radiomedix.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2019 | Apr 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 6, 2019 | Apr 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C575629 | 64Cu-DOTATATE |
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| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells.
64Cu-DOTATATE: Detection of somatostin positive lesions in NET
|
|
| Primary | Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor | The number of subjects who have no SSTR (+) NETs as determined by 64Cu-DOTATATE PET/CT as well using the standard of truth imaging (In111-Octrescan SPECT/CT). | The specificity of 64Cu-DOTATATE imaging has defined the ability of a radiotracer to correctly identify subjects who do not have a disease. It is defined by number of subjects who had no SSTR(+) NETs based on 64Cu-DOTATATE PET/CT imaging as well as SOT imaging using In111-Octreoscan. | Posted | Count of Participants | Participants | No | 12 months |
|
|
|
| Secondary | Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging | The number of patients with localized NETs or metastatic SSTR(+) neuroendocrine tumors that were detected by both 64Cu-DOTATATE and SOT | A number of subjects with localized SSTR(+) NETs or metastatic NETs detected by both Cu64-DOTATATE and SOT | Posted | Count of Participants | Participants | No | 12 months |
|
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|
| 0 |
| 63 |
| 0 |
| 63 |
| 5 |
| 63 |
|
| headache (grade 1) | General disorders | MeDRA 10 | Systematic Assessment |
|
| syncope (grade 2) | General disorders | MeDRA 10 | Systematic Assessment |
|
| melanoderma (grade 1) | General disorders | MeDRA 10 | Systematic Assessment |
|
| flushing (grade 1) | General disorders | MeDRA 10 | Systematic Assessment |
|
| vomiting (both grade 1) | General disorders | MeDRA 10 | Systematic Assessment |
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| D009380 | Neoplasms, Nerve Tissue |
| metastatic NETs true negative |
|