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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02691078
Enrollment
15
Registered
2016-02-25
Start date
2016-07-31
Completion date
2018-01-10
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

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.

Interventions

OTHER99m 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

Sponsors

Financiadora de Estudos e Projetos
CollaboratorOTHER
Instituto do Cérebro do Rio Grande do Sul - InsCer
CollaboratorUNKNOWN
Latin American Cooperative Oncology Group
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 tumorsUp to 30 days

Secondary

MeasureTime frame
Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agentsUp to 30 days
Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agentsUp to 30 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026