Clinical trial NCT03673943: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuroendocrine Tumors
Lead sponsor: Radiomedix, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor
timeFrame: 12 months
measure: Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor
timeFrame: 12 months
Secondary outcomes:
measure: Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging
timeFrame: 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Excel Diagnostics and Nuclear Oncology Center
state: Texas
Study officials:
affiliation: Radiomedix, Inc.
name: Ebrahim S Delpassand, MD
role: STUDY_DIRECTOR
References:
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.