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

Phase 1

Recruiting

• Conditions: Medullary Thyroid Carcinoma
• Interventions: Drug: 68Ga-MGS5

• Registration Number: NCT06520319
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-06-21
• Status Verified: 2024-07
• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-21
• Last Update Submitted: 2024-07-21
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 Criteria

• Pregnant or breastfeeding female patients
• Patients with claustrophobic behavior
• The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients will undergo a 68Ga-MGS5 PET/CTF and 68Ga-DOTATATE PET/CT	68Ga-MGS5	MTC Patients received 68Ga-DOTATATE PET/CT imaging and a single injection of 68Ga-MGS5 and two PET/CT scans 1 hour and 2 hours after the injection within one week.

Primary Outcome Measures

Name	Time	Method
SUVmax and SUVpeak	through study completion, an average of 2 years	Determination of SUVmean and SUVpeak for detected lesions and discernible organs of 68Ga-MGS5 and 68Ga-DOTATATE scan.

Secondary Outcome Measures

Name	Time	Method
immunohistochemistry	through study completion, an average of 2 years	Primary and lymph node metastases were stained with CCK2 immunohistochemistry and scored.

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China