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

NCT ID: NCT03673943

Last Updated: 2022-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2019-08-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Neuroendocrine Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET/CT imaging with 64Cu-DOTATATE

64Cu-DOTATATE is an investigational radioactive drug that binds to somatostatin receptors on neuroendocrine cancer cells.

Group Type EXPERIMENTAL

64Cu-DOTATATE

Intervention Type DRUG

Detection of somatostatin positive lesions in NET

Interventions

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64Cu-DOTATATE

Detection of somatostatin positive lesions in NET

Intervention Type DRUG

Other Intervention Names

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NETMEDIX

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radiomedix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ebrahim S Delpassand, MD

Role: STUDY_DIRECTOR

Radiomedix, Inc.

Locations

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Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31924723 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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131797

Identifier Type: -

Identifier Source: org_study_id