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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691078
• Other study ID #: LACOG 0214
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: January 10, 2018

Study information

• Verified date: August 2023
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 10, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto do Cérebro do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	Financiadora de Estudos e Projetos, Instituto do Cérebro do Rio Grande do Sul - InsCer

Country where clinical trial is conducted

Brazil, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents		Up to 30 days
Secondary	Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents		Up to 30 days

External Links

•   Disclosure of the study on the sponsor's website.