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

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ClinicalTrials.gov Identifier: NCT02691078
Recruitment Status : Unknown
Verified July 2016 by Latin American Cooperative Oncology Group.
Recruitment status was:  Recruiting
First Posted : February 25, 2016
Last Update Posted : August 9, 2016
Sponsor:
Collaborators:
Financiadora de Estudos e Projetos
Instituto do Cérebro do Rio Grande do Sul - InsCer
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Other: 99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02691078


Contacts
Contact: Laura Voelcker 55 51 3384 5334 laura.voelcker@lacog.org.br
Contact: Raíra Maschmann 55 51 3384 5334 raira.maschmann@lacog.org.br

Locations
Brazil
Instituto do Cérebro do Rio Grande do Sul Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Cristina Moriguchi, PhD         
Sponsors and Collaborators
Latin American Cooperative Oncology Group
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:
Vallabhajosula, S. Molecular Imaging: radiopharmaceuticals for PET and SPECT. New York: Springer, 2009. 371p

Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT02691078     History of Changes
Other Study ID Numbers: LACOG 0214
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Octreotide
EDDA
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action