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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • 68Ga-MGS5

    Drug

    Each patient received a single intravenous injection of 68Ga-DOTATATE (2-4 mCi) and underwent PET/CT scanning 40-60 minutes after the injection. Or receive one intravenous injection of 68Ga-MGS5 and undergo two PET/CT scans at 1 and 2 hours post-injection, respectively.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patients will undergo a 68Ga-MGS5 PET/CTF and 68Ga-DOTATATE PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

SUVmax and SUVpeak

Determination of SUVmean and SUVpeak for detected lesions and discernible organs of 68Ga-MGS5 and 68Ga-DOTATATE scan.

Time frame
through study completion, an average of 2 years

Secondary outcomes

1

immunohistochemistry

Primary and lymph node metastases were stained with CCK2 immunohistochemistry and scored.

Time frame
through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

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