Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma

Last updated: July 21, 2024
Sponsor: First Affiliated Hospital of Fujian Medical University
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Thyroid Disorders

Treatment

68Ga-MGS5

Clinical Study ID

NCT06520319
FirstAHFujian-68Ga-MGS5
  • Ages 18-80
  • All Genders

Study Summary

Cholecystokinin-2 (CCK2) receptor is overexpressed in more than 90% of MTC cases, and preclinical studies have shown that 68Ga-MGS5 (targeting CCK2) has good stability in vivo and is promising for diagnosis and staging of MTC. This prospective study will compare the diagnostic effects of 68Ga-MGS5 and 68Ga-DOTATATE on MTC primary foci, lymph node metastasis, and distant metastasis, and explore the effect of 68Ga-MGS5 PET/CT on the clinical staging (TNM staging) of MTC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of either gender, aged ≥ 18 years and ≤80 years.

  • Patients with pathologic findings confirming the diagnosis of MTC

  • Patients with MTC recurrence

  • Signed written consent

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding female patients

  • Patients with claustrophobic behavior

  • The inability or unwillingness of the research participant, parent or legalrepresentative to provide written informed consent

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: 68Ga-MGS5
Phase: 1
Study Start date:
June 21, 2023
Estimated Completion Date:
July 31, 2025

Study Description

This study was planned to enroll 20 patients with suspected MTC and MTC recurrence who attended the First Hospital of Fujian Medical University from June 2023 onwards. Each patient completed PET/CT examination within 1 week, one 68Ga-DOTATATE PET/CT whole-body examination and two 68Ga-MGS5 PET/CT whole-body examinations (1 hour and 2 hours after injection, respectively). CCK2 immunohistochemical staining and expression scoring of primary foci and lymph node metastases were also performed.

Connect with a study center

  • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Active - Recruiting

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