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

Primary Purpose

Neuroendocrine Tumors

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide
Sponsored by
Latin American Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto do Cérebro do Rio Grande do Sul

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adult patients with neuroendocrine tumors

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents
Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents

Full Information

First Posted
February 11, 2016
Last Updated
August 29, 2023
Sponsor
Latin American Cooperative Oncology Group
Collaborators
Financiadora de Estudos e Projetos, Instituto do Cérebro do Rio Grande do Sul - InsCer
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1. Study Identification

Unique Protocol Identification Number
NCT02691078
Brief Title
Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
Official Title
Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Latin American Cooperative Oncology Group
Collaborators
Financiadora de Estudos e Projetos, Instituto do Cérebro do Rio Grande do Sul - InsCer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adult patients with neuroendocrine tumors
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents
Time Frame
Up to 30 days
Title
Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Werutsky, MD
Organizational Affiliation
Latin American Cooperative Oncology Group
Official's Role
Study Director
Facility Information:
Facility Name
Instituto do Cérebro do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
37533941
Citation
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.
Results Reference
result
Links:
URL
http://lacogcancerresearch.org/studies/clinical-trials/closed/lacog-0214-finep/
Description
Disclosure of the study on the sponsor's website.

Learn more about this trial

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

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