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Novel 99mTc-labeled Somatostatin Antaginosts in the Diagnostic Algotithm of Neuroendocrine Neoplasms

NCT05871320 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-09-29

No results posted yet for this study

Summary

The main goal of the study is to expand cancer preclinical research results on the usefulness of SSTR2-Antagonist \[99mTc\]Tc-TECANT1 in clinical practice. Detection of NEN and monitoring of response to therapy is still challenging due to their cellular heterogeneity. Initial preclinical studies suggest that NEN imaging with the use of SSTR2-Antagonist may be advantageous in comparison to the widely used SSTR2-Agonists.

Recently, novel radiopharmaceuticals, based on SSTR2-Antagonists, were shown to provide superior SSTR2 visualisation than currently used agonists. The need for molecular imaging of NEN is expected to grow significantly in the near future due to their increasing incidence and prevalence. Although a persistent trend to shift the molecular imaging of NEN from conventional SPECT/CT gamma cameras to PET/CT has been observed in the last decade, labelling the compound with Tc-99m offers significant advantages by its extremely wide availability, low cost and low radiation exposure to patients. Effective and accessible molecular imaging methods as an integral part of personalised patient management are needed to optimise selection and follow-up of available therapeutic modalities. The Tc-99m-labeled SSTR2-Antagonist \[99mTc\]Tc-TECANT1 is expected to be an effective, widely available compound for quantitative assessment of SSTR2 NEN status, allowing a personalised therapeutic approach.

Conditions

Interventions

DRUG

[99mTc]Tc-TECANT1

only one arm - the administration of \[99mTC\]-Tc-TECANT1 in all patients included

Sponsors & Collaborators

  • Medical University Innsbruck

    collaborator OTHER

  • NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom

    collaborator INDUSTRY

  • University of Ljubljana

    collaborator OTHER

  • University Medical Centre Ljubljana

    collaborator OTHER

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Alicja Hubalewska-Dydejczyk, Prof. · Endocrinology Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-23
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Austria
  • Poland
  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05871320 on ClinicalTrials.gov