Trial record 4 of 88 for:
somatostatin receptor | Neuroendocrine Tumors
Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE
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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: NCT03673943 |
Recruitment Status :
Completed
First Posted : September 17, 2018
Last Update Posted : July 23, 2019
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Sponsor:
Radiomedix, Inc.
Information provided by (Responsible Party):
Radiomedix, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | August 23, 2018 | ||||
First Posted Date ICMJE | September 17, 2018 | ||||
Last Update Posted Date | July 23, 2019 | ||||
Actual Study Start Date ICMJE | August 23, 2018 | ||||
Actual Primary Completion Date | March 23, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Determine sensitivity and specificity on a per-subject basis of 64Cu-DOTATATE PET-CT imaging for detection of tumor location [ Time Frame: 12 months ] The detection of tumor location using Cu64-DOTATATE will be done in subjects with known or suspected NETs, when comparing individual reader results of PET/CT scans to a standard of truth (SOT) for each subject.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Determine the positive predictive value (PPV) of 64Cu- PSMA PET/CT for detection of neuroendocrine tumor on a per-patient basis. [ Time Frame: 12 months ] To characterize the predictive value of 64Cu-DOTATATE PET-CT imaging, the standard of truth results (SOT) results for each subject will be compared to results from PET/CT imaging ( based on the individual reader results and based on the reader-majority rule determination).
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE | ||||
Official Title ICMJE | An Open-label, Single-dose, Single Arm, Single-center Clinical Trial of 64Cu-DOTATATE (NETMedix™) PET-CT Scan for Imaging Patients With Known or Suspected Somatostatin Receptor-positive Neuroendocrine Tumors (NETs) | ||||
Brief Summary | This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer. | ||||
Detailed Description | 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 PET/CT and /or F-18 NaF bone PET/CT and/or bone scintigraphy, and/or Octreoscan. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Neuroendocrine Tumors | ||||
Intervention ICMJE | Drug: 64Cu-DOTATATE
Detection of somatostin positive lesions in NET
Other Name: NETMEDIX
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Study Arms ICMJE | Experimental: PET/CT imaging with 64Cu-DOTATATE
64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells.
Intervention: Drug: 64Cu-DOTATATE
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
59 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 23, 2019 | ||||
Actual Primary Completion Date | March 23, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03673943 | ||||
Other Study ID Numbers ICMJE | 131797 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Radiomedix, Inc. | ||||
Study Sponsor ICMJE | Radiomedix, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Radiomedix, Inc. | ||||
Verification Date | July 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |