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

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ClinicalTrials.gov Identifier: NCT03673943

Recruitment Status : Completed

First Posted : September 17, 2018

Last Update Posted : July 23, 2019

Sponsor:

Information provided by (Responsible Party):

Radiomedix, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Neuroendocrine Tumors	Drug: 64Cu-DOTATATE	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	59 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
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)
Actual Study Start Date :	August 23, 2018
Actual Primary Completion Date :	March 23, 2019
Actual Study Completion Date :	March 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diagnostic Imaging

Drug Information available for: Somatostatin

Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: PET/CT imaging with 64Cu-DOTATATE 64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on NETs cancer cells.	Drug: 64Cu-DOTATATE Detection of somatostin positive lesions in NET Other Name: NETMEDIX

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673943

Locations

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United States, Texas
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States, 77042

Sponsors and Collaborators

Radiomedix, Inc.

Investigators

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

More Information

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Responsible Party:	Radiomedix, Inc.
ClinicalTrials.gov Identifier:	NCT03673943 History of Changes
Other Study ID Numbers:	131797
First Posted:	September 17, 2018 Key Record Dates
Last Update Posted:	July 23, 2019
Last Verified:	July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms	Neoplasms, Nerve Tissue Somatostatin Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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