Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2018
CompletedFebruary 4, 2025
February 1, 2025
1.5 years
February 11, 2016
February 3, 2025
Conditions
Outcome Measures
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
Up to 30 days
Secondary Outcomes (2)
Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents
Up to 30 days
Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents
Up to 30 days
Study Arms (1)
Adult patients with neuroendocrine tumors
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant women
- Patients with previous tumor resection of the primary tumor without metastatic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto do Cérebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (1)
Moriguchi-Jeckel CM, Madke RR, Radaelli G, Viana A, Nabinger P, Fernandes B, Gossling G, Berdichevski EH, Vilas E, Giacomazzi J, Rocha MS, Borges JA, Hoffmann E, Greggio S, Venturin GT, Barrios CH, Zaffaroni F, Werutsky G, da Costa JC. Clinical validation and diagnostic accuracy of 99mTc-EDDA/HYNIC-TOC compared to 111In-DTPA-octreotide in patients with neuroendocrine tumours: the LACOG 0214 study. Ecancermedicalscience. 2023 Jul 26;17:1582. doi: 10.3332/ecancer.2023.1582. eCollection 2023.
PMID: 37533941RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gustavo Werutsky, MD
Latin American Cooperative Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2016
First Posted
February 25, 2016
Study Start
July 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 10, 2018
Last Updated
February 4, 2025
Record last verified: 2025-02