Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE
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|ClinicalTrials.gov Identifier: NCT03673943|
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: 64Cu-DOTATATE||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||August 23, 2018|
|Actual Primary Completion Date :||March 23, 2019|
|Actual Study Completion Date :||March 23, 2019|
Experimental: PET/CT imaging with 64Cu-DOTATATE
64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells.
Detection of somatostin positive lesions in NET
Other Name: NETMEDIX
- 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.
- 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).
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): NCT03673943
|United States, Texas|
|Excel Diagnostics and Nuclear Oncology Center|
|Houston, Texas, United States, 77042|
|Study Director:||Ebrahim S Delpassand, MD||Radiomedix, Inc.|