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

• ClinicalTrials.gov Identifier: NCT03673943
• Recruitment Status: Completed
• First Posted: September 17, 2018
• Last Update Posted: July 23, 2019
• Sponsor: Radiomedix, Inc.
• Information provided by (Responsible Party): Radiomedix, Inc.

Tracking Information

• First Submitted Date: August 23, 2018
• First Posted Date: September 17, 2018
• Last Update Posted Date: July 23, 2019
• Actual Study Start Date: August 23, 2018
• Actual Primary Completion Date: March 23, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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-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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Neuroendocrine Tumors

Intervention

Drug: 64Cu-DOTATATE

Detection of somatostin positive lesions in NET

Other Name: NETMEDIX

Study Arms

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 13, 2018): 59
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 23, 2019
• Actual Primary Completion Date: March 23, 2019 (Final data collection date for primary outcome measure)

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® 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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03673943
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Radiomedix, Inc.
• Study Sponsor: Radiomedix, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Ebrahim S Delpassand, MD; Radiomedix, Inc.

• PRS Account: Radiomedix, Inc.
• Verification Date: July 2019