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

Neuroendocrine Tumors Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673943
• Other study ID #: 131797
• Status: Completed
• Phase: Phase 3
• Start date: August 23, 2018
• Est. completion date: August 7, 2019

Study information

• Verified date: November 2022
• Source: Radiomedix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 7, 2019
• Est. primary completion date: March 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• 64Cu-DOTATATE
Detection of somatostatin positive lesions in NET

Locations

Country	Name	City	State
United States	Excel Diagnostics and Nuclear Oncology Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Radiomedix, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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).	12 months
Secondary	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	12 months

External Links

•   Detectnet (copper Cu 64 dotatate injection), for intravenous use Initial U.S. Approval: 2020