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Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE

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
Sponsor:
Information provided by (Responsible Party):
Radiomedix, Inc.

Tracking Information
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
 (submitted: September 13, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03673943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
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).
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 Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: 64Cu-DOTATATE
Detection of somatostin positive lesions in NET
Other Name: NETMEDIX
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2018)
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:

  • 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® LAR and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® LAR or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radiomedix, Inc.
Study Sponsor  ICMJE Radiomedix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ebrahim S Delpassand, MD Radiomedix, Inc.
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