Back to resultsImaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
64Cu-DOTATATE
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
- Confirmed or suspicion of NET based on histology/ biopsy report.
- Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET
- CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date.
Exclusion Criteria:
- Pregnant, planning to be pregnant within the next two weeks
- Inability to provide written consent.
- Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.
Sites / Locations
- Excel Diagnostics and Nuclear Oncology Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET/CT imaging with 64Cu-DOTATATE
Arm Description
64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on neuroendocrine cancer cells.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03673943
Brief Title
Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE
Official Title
An Open-label, Single-dose, Single Arm, Single-center Clinical Trial of 64Cu(Copper)-DOTATATE (NETMedix™) PET-CT Scan for Imaging Patients With Known or Suspected Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
March 23, 2019 (Actual)
Study Completion Date
August 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiomedix, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 fluorodeoxyglucose PET (positron emission tomography)/CT and /or F-18 NaF sodium fluoride bone PET/CT and/or bone scintigraphy, and/or Octreoscan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/CT imaging with 64Cu-DOTATATE
Arm Type
Experimental
Arm Description
64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on neuroendocrine cancer cells.
Intervention Type
Drug
Intervention Name(s)
64Cu-DOTATATE
Other Intervention Name(s)
NETMEDIX
Intervention Description
Detection of somatostatin positive lesions in NET
Primary Outcome Measure Information:
Title
Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor
Description
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.
Time Frame
12 months
Title
Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging
Description
The number of patients with localized NETs or metastatic SSTR(+) neuroendocrine tumors that were detected by both 64Cu-DOTATATE and SOT
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Confirmed or suspicion of NET based on histology/ biopsy report.
Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET
CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date.
Exclusion Criteria:
Pregnant, planning to be pregnant within the next two weeks
Inability to provide written consent.
Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebrahim S Delpassand, MD
Organizational Affiliation
Radiomedix, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Excel Diagnostics and Nuclear Oncology Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31924723
Citation
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.
Results Reference
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Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE
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