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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 1

Conditions: Medullary Thyroid Carcinoma

Treatments: Drug: 68Ga-MGS5

Study type: Interventional

Funder types: Other

Identifiers

NCT06520319

FirstAHFujian-68Ga-MGS5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients will undergo a 68Ga-MGS5 PET/CTF and 68Ga-DOTATATE PET/CT

Experimental group

Description:

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.

Treatment:

Drug: 68Ga-MGS5