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

Radiomedix, Inc.63 enrolled

Overview

This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Neuroendocrine Tumors

Interventions

64Cu-DOTATATEDRUG

Detection of somatostatin positive lesions in NET

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

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).

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.