NCT03673943

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

December 22, 2022

Completed
Last Updated

December 22, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

August 23, 2018

Results QC Date

April 22, 2021

Last Update Submit

November 30, 2022

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging

    12 months

Study Arms (1)

PET/CT imaging with 64Cu-DOTATATE

EXPERIMENTAL

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

Drug: 64Cu-DOTATATE

Interventions

64Cu-DOTATATEDRUG

Detection of somatostatin positive lesions in NET

Also known as: NETMEDIX
PET/CT imaging with 64Cu-DOTATATE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, 77042, United States

Location

Related 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.

    PMID: 31924723BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

64Cu-DOTATATE

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Results Point of Contact

Title
Ebrahim Delpassand
Organization
RadioMedix Inc
edelpassand@radiomedix.com
7134999733

Study Officials

  • Ebrahim S Delpassand, MD

    Radiomedix, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

September 17, 2018

Study Start

August 23, 2018

Primary Completion

March 23, 2019

Study Completion

August 7, 2019

Last Updated

December 22, 2022

Results First Posted

December 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)