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



Status:Recruiting
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/19/2018
Start Date:August 23, 2018
End Date:August 23, 2019
Contact:Susan Cork
Email:scork@exceldiagnostics.com
Phone:713-781-6200

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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)

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 PET/CT
and /or F-18 NaF bone PET/CT and/or bone scintigraphy, and/or Octreoscan.

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.
We found this trial at
1
site
Houston, Texas 77042
Principal Investigator: Luke Bolek, MD
Phone: 713-341-3203
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from
Houston, TX
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