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NCT02691078·Phase 2·INTERVENTIONAL

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

OctreotideOtherCompleted

Status

Completed

Phase

Phase 2

Enrollment

15

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Feb 25, 2016

  2. Study start

    Jul 2016

  3. Primary completion

    Jan 2018

  4. Study completion

    Jan 10, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Feb 4, 2025

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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

Time frame · Up to 30 days

Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents

Time frame · Up to 30 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

Brazil. Showing up to 24 locations stored in the fast local snapshot.

Instituto do Cérebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Publications

Results and literature.

PMID 37533941 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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