Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors

August 29, 2023 updated by: Latin American Cooperative Oncology Group
Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the 111In - DTPA-octreotide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Instituto do Cerebro do Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with histological diagnosis of neuroendocrine tumors
  • Patients with indication for the staging exam with 11In
  • Patients diagnosed in any tumor stage
  • Patients with > 18 years
  • Male and female patients
  • Patients not receiving somatostatin analogues for at least 1 month before image capturing

Exclusion Criteria:

  • Pregnant women
  • Patients with previous tumor resection of the primary tumor without metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult patients with neuroendocrine tumors
Other: 99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide
The patient will undercome an PET/CT exam with 99m Tc - HYNIC -TOC EDDA, after 20 days of wash out, the same patient will undercome the same exam with 111In - DTPA-octreotide in order to compare both radiopharmaceuticals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of the images captured with 99m Tc - HYNIC -TOC EDDA ( octreotide labeled with 99mTc ) and 111In - DTPA-octreotide for the diagnosis of neurocrine tumors
Time Frame: Up to 30 days
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents
Time Frame: Up to 30 days
Up to 30 days
Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents
Time Frame: Up to 30 days
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

Collaborators

Financiadora de Estudos e Projetos
Instituto do Cérebro do Rio Grande do Sul - InsCer

Investigators

  • Study Director: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 10, 2018

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimated)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 0214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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