Study NCT03673943
Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE
Submitted Date:  April 22, 2021 (v3)
Quality Control Review Has Not Concluded

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Open or close this module Study Identification
Unique Protocol ID: 131797
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2019
Overall Status: Completed
Study Start: August 23, 2018
Primary Completion: March 23, 2019 [Actual]
Study Completion: August 7, 2019 [Actual]
First Submitted: August 23, 2018
First Submitted that
Met QC Criteria:
September 13, 2018
First Posted: September 17, 2018 [Actual]
Results First Submitted: April 22, 2021
Results First Submitted that
Met QC Criteria:
Results First Posted: May 17, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
Last Update Posted: May 17, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Radiomedix, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Open or close this module Conditions
Conditions: Neuroendocrine Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 63 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PET/CT imaging with 64Cu-DOTATATE
64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on neuroendocrine cancer cells.
Drug: 64Cu-DOTATATE
Detection of somatostatin positive lesions in NET
Other Names:
  • NETMEDIX
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. 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 co-primary effectiveness endpoints of the study were the sensitivity and specificity of 64Cu-DOTATATE PET-CT imaging when each imaging reader's subject-level result was compared to a SOT (standard of therapy) for the subject, with primary endpoint success defined as the same two out of three readers having sensitivity and specificity results exceeding the specified thresholds.

Quality Control Review Comment provided by the National Library of Medicine:

  1. More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent.
Secondary Outcome Measures:
1. Determine the Positive Predictive Value (PPV) of 64Cu- DOTATATE PET/CT for Detection of Neuroendocrine Tumor on a Per-patient Basis.
[ Time Frame: 12 months ]

The secondary effectiveness endpoints of the study were the majority of readers sensitivity, specificity, PPV, NPV, and accuracy; individual and majority reader sensitivity and specificity in distinguishing between localized and metastatic disease; and individual reader accuracy, PPV, and NPV ( negative predictive value)

Quality Control Review Comment provided by the National Library of Medicine:

  1. More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Study Officials: Ebrahim S Delpassand, MD
Study Director
Radiomedix, Inc.
Locations: United States, Texas
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States, 77042
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: Delpassand ES, Ranganathan D, Wagh N, Shafie A, Gaber A, Abbasi A, Kjaer A, Tworowska I, Núñez R. (64)Cu-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. PubMed 31924723
Links: Description: Detectnet (copper Cu 64 dotatate injection), for intravenous use Initial U.S. Approval: 2020
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: March 9, 2019
Uploaded: 04/22/2021 14:10
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: March 9, 2019
Uploaded: 04/22/2021 14:11
File Name: SAP_001.pdf

Quality Control Review Comment provided by the National Library of Medicine:

  1. Some information appears inappropriate where reported.
Study Results
Open or close this module Participant Flow
Recruitment Details

Number of Subjects (planned and analyzed):

Analyzed: The study enrolled 66 subjects including 4 subjects from the Phase 1 study. 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.

Pre-assignment Details
 
Arm/Group Title PET/CT Imaging With 64Cu-DOTATATE
Arm/Group Description

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

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Enrollment number appears inconsistent with information in other parts of the record.
Period Title: Overall Study
Started 63
Completed 63
Not Completed 0
Open or close this module Baseline Characteristics
   
Arm/Group TitlePET/CT Imaging With 64Cu-DOTATATE
Arm/Group Description

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

Overall Number of Baseline Participants 63
Baseline Analysis Population Description
Age, Categorical
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed63 Participants
<=18 years0 0%
Between 18 and 65 years54 85.71%
>=65 years9 14.29%
Age, Continuous
Median (Standard Deviation)
Unit of measure: years
Number Analyzed63 Participants
54.37(15.65)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed63 Participants
Female35 55.56%
Male28 44.44%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed63 Participants
Hispanic or Latino11 17.46%
Not Hispanic or Latino52 82.54%
Unknown or Not Reported0 0%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed63 Participants
American Indian or Alaska Native0 0%
Asian2 3.17%
Native Hawaiian or Other Pacific Islander0 0%
Black or African American6 9.52%
White54 85.71%
More than one race0 0%
Unknown or Not Reported1 1.59%
Open or close this module Outcome Measures
1. Primary Outcome:
Title Determine Sensitivity and Specificity on a Per-subject Basis of 64Cu-DOTATATE PET-CT Imaging for Detection of Tumor Location
Description The co-primary effectiveness endpoints of the study were the sensitivity and specificity of 64Cu-DOTATATE PET-CT imaging when each imaging reader's subject-level result was compared to a SOT (standard of therapy) for the subject, with primary endpoint success defined as the same two out of three readers having sensitivity and specificity results exceeding the specified thresholds.
Time Frame 12 months

Quality Control Review Comment provided by the National Library of Medicine:

  1. More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent.
Outcome Measure Data
Analysis Population Description
Two of the three readers had point estimates of specificity greater ≥90% while the third had a point estimate of specificity equal to 80% in determining absence of disease when disease was indeed absent. All readers passed the sensitivity and specificity hypotheses testing at a one-sided α=0.025 level of significance.
 
Arm/Group TitlePET/CT Imaging With 64Cu-DOTATATE
Arm/Group Description

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

Overall Number of Participants Analyzed63
Overall Number of Units Analyzed
Type of Units Analyzed: percentage
63
Number (95% Confidence Interval)
Unit of Measure: percentage
0.9 (0.7438 to 0.9654)

Quality Control Review Comment provided by the National Library of Medicine:

  1. The Type and Number of Units Analyzed appear to be used inappropriately.
  2. A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format.
2. Secondary Outcome:
Title Determine the Positive Predictive Value (PPV) of 64Cu- DOTATATE PET/CT for Detection of Neuroendocrine Tumor on a Per-patient Basis.
Description The secondary effectiveness endpoints of the study were the majority of readers sensitivity, specificity, PPV, NPV, and accuracy; individual and majority reader sensitivity and specificity in distinguishing between localized and metastatic disease; and individual reader accuracy, PPV, and NPV ( negative predictive value)
Time Frame 12 months

Quality Control Review Comment provided by the National Library of Medicine:

  1. More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent.
Outcome Measure Data
Analysis Population Description
The majority of readers showed statistically significant sensitivity (0.9091, p=0.0042) and specificity (0.9655, p<0.0001) in detecting patients positive for disease and patients negative for disease, respectively. The probability of disease being present given a positive result with 64Cu-DOTATATE (PPV) was 0.9677.
 
Arm/Group TitlePET/CT Imaging With 64Cu-DOTATATE
Arm/Group Description

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

Overall Number of Participants Analyzed63
Number (95% Confidence Interval)
Unit of Measure: score on a scale
0.9677 (0.8381 to 0.9943)

Quality Control Review Comment provided by the National Library of Medicine:

  1. A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format.
  2. The Unit of Measure appears inconsistent with the Measure Title, the Measure Description, or both.
Open or close this module Adverse Events
 
Time Frame 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
Adverse Event Reporting Description Overall there were 9 adverse events experienced by 5 subjects. The most common adverse events were gastrointestinal disorders (4.8%), nervous system disorders (3.2%), vascular disorders (3.2%), and skin and subcutaneous tissue disorders (1.6%).

Quality Control Review Comment provided by the National Library of Medicine:

  1. A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format.
 
Arm/Group Title PET/CT Imaging With 64Cu-DOTATATE
Arm/Group Description

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

All-Cause Mortality
  PET/CT Imaging With 64Cu-DOTATATE
 Affected/At Risk (%)# Events
Total 0 / 63 (0%)
Serious Adverse Events
  PET/CT Imaging With 64Cu-DOTATATE
 Affected/At Risk (%)# Events
Total 0 / 63 (0%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
  PET/CT Imaging With 64Cu-DOTATATE
 Affected/At Risk (%)# Events
Total 5 / 63 (7.94%)
Gastrointestinal disorders
nausea, vomiting A [1]† 5 / 63 (7.94%)5
Indicates events were collected by systematic assessment.
ATerm from vocabulary, MeDRA 10
[1]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
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact:
Name/Official Title:
Ebrahim Delpassand
Organization:
RadioMedix Inc
Phone:
7134999733
Email:
edelpassand@radiomedix.com

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