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Completed

NCT Number: NCT02691078

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

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.

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Instituto do Cérebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents

    Time frame: Up to 30 days

  2. Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents

    Time frame: Up to 30 days

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2016
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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